[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,53,85,109,140,161,194,226,255,282,311,342,370,392,417,450,478,503,532,559,587,613,637,657,679],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809",false,"NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply","ALL","18 Years","100 Years",{"count":22,"type":23},1400,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[29],"Early Breast Cancer",[31,32,33,34,35,36,37,38,39],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)","RECRUITING","2026-07-01",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":44},"2024-02-28",{"date":48,"type":23},"2030-09-20",{"name":50,"class":51},"Novartis Pharmaceuticals","INDUSTRY",223,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100645014","phase-2-clinical-study-of-local-and-systemic-biological-impact-of-glp1gip-receptor-agonists-in-patients-with-breast-cancer-the-clara-trial-100645014","NCT07676331","Clinical Study of Local and Systemic Biological Impact of GLP1\u002FGIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial","CLARA","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures\n2. Patient is \\>18 years of age\n3. Patient is postmenopausal, as defined per local practice\n4. Tumour size of ≥1 cm\n5. The patient has a biopsy-confirmed diagnosis of GII-III ER+, HER2 - early stage breast cancer scheduled for primary surgery as per standard-of-care\n\n   1. To fulfil the requirement for HR+ disease by local testing on primary disease specimen, tumour must be ER positive defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines for hormone receptor testing.\n   2. To fulfil the requirement of HER2- disease by local testing on primary disease specimen, tumour must be HER2- according to ASCO\u002FCAP guidelines for HER2 testing\n   3. All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (IBC-NST) , invasive lobular carcinoma (ILC) etc.\n6. Have a BMI of\n\n   1. ≥30 kg\u002Fm2 or\n   2. ≥27 kg\u002Fm2 and previously diagnosed with at least 1 of the following weight-related comorbidities:\n\n   i. Hypertension: treated or with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg ii. Dyslipidaemia: treated or with LDL ≥160 mg\u002FdL (4.1 mmol\u002FL) or triglycerides ≥150 mg\u002FdL (1.7 mmol\u002FL), or HDL iii. Obstructive sleep apnoea iv. Cardiovascular disease, for example, ischemic cardiovascular disease, New York Heart Association Functional Classification Class I-III heart failure\n7. Patient should be able to read\u002Funderstand Dutch, French or English\n8. Willing to commit to the study program and comply with all related protocol procedures\n9. Willing to undergo a new biopsy of the breast lesion in case no formalin-fixed paraffin-embedded (FFPE) block can be made available for the trial.\n\nExclusion Criteria:\n\n1. Have Type 1 or 2 diabetes mellitus, history of ketoacidosis, or hyperosmolar state or coma.\n2. Have at least 1 laboratory value suggestive of diabetes during screening : HbA1c ≥6.5% (≥48 mmol\u002Fmol) or fasting glucose ≥126 mg\u002FdL (≥7.0 mmol\u002FL)\n3. Have a history of BC exceptions are made for:\n\n   1. Contralateral in situ BC without systemic treatment\n   2. Ipsilateral in situ BC without systemic treatment or radiation therapy\n4. Have a history of an additional invasive malignancy that is progressing or that has required active treatment in the 3 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n5. Are receiving or has received within 3 months prior to screening systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have evidence of a significant, active autoimmune that has required (within the last 3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with systemic treatment (such as glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations)) during the course of the study.\n\n   Note: Replacement therapy with thyroxine is not a contraindication for inclusion if patient is already on same dose for 3 months\n6. Have a history of any other condition, such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder, that, in the opinion of the investigator, may preclude the participant from following and completing the protocol\n7. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n8. Have a self-reported change in body weight \\>5 kg within 3 months prior to screening\n9. Have a prior surgical treatment for obesity, excluding liposuction or abdominoplasty\n10. Have endoscopic and\u002For device-based therapy for obesity or have had device removal within the last 6 months prior to screening\n11. Have renal impairment measured as eGFR \\\u003C30L\u002Fmin\u002F1.73m2\n12. Have a known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility\n13. Have a history of chronic or acute pancreatitis\n14. Is treated with insulin or other hypoglycaemic drugs\n15. Participation in another interventional Trial with an investigational medicinal product (IMP) or device in the neoadjuvant setting\n16. Have obesity induced by other endocrinologic disorders, for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity\n17. Has acute or chronic hepatitis, signs and symptoms of any other liver disease other than NAFLD, or any of the following, as determined by the central laboratory during screening:\n\n    1. Alanine aminotransferase (ALT) level \\>3.0x ULN for the reference range\n    2. Alkaline phosphatase (ALP) level \\>2.0x ULN for the reference range, or\n    3. Total bilirubin level \\>1.5x ULN for the reference range (except for cases of known Gilbert's Syndrome) Note: Participants with non-alcoholic fatty liver disease (NAFLD) are eligible to participate in this trial if their ALT level is ≤3.0x ULN for the reference range\n18. Has used systemic hormonal substitution therapy within 2 months before screening\n19. Has used a GLP1\u002F(GIP)\u002F(GC) Receptor Agonist within 2 months of screening\n20. Has used medications (prescribed or over-the-counter) within 2 months prior to screening that promote weight loss.","FEMALE",{"count":62,"type":23},168,[64],"PHASE2","The CLARA trial is a phase II window-of-opportunity trial evaluating how a commonly used weight-loss medication (tirzepatide, a GLP-1\u002FGIP receptor agonist) affects breast cancer biology, alone and in combination with standard hormone therapy (letrozole).\n\nThe main goal is to determine whether tirzepatide, alone or combined with letrozole, reduces tumor cell growth.",[67,29],"Hormone-receptor-positive Breast Cancer",[69,70,71,72,73],"GLP-1\u002FGIP receptor agonist","tirzepatide","letrozole","Window-of-opportunity trial","Weight-loss drugs","NOT_YET_RECRUITING","2026-06-23",{"date":77,"type":44},"2026-06-30",{"date":79,"type":23},"2026-08-01",{"date":81,"type":23},"2028-05-01",{"name":83,"class":84},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":24,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100634545","phase-3-a-study-evaluating-adherence-tolerability-and-patient-reported-outcomes-of-giredestrant-in-participants-with-erher2--early-breast-cancer-who-are-intolerant-to-adjuvant-aromatase-inhibitor-therapy-novera-breast-cancer-100634545","NCT07541079","A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+\u002FHER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)","A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+\u002FHER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy","Inclusion Criteria:\n\n* Considered appropriate for treatment with endocrine therapy (ET)\n* Histologically confirmed diagnosis of ER+\u002FHER2-, Stage I-III (low-\u002Fmedium-\u002Fhigh-risk) early breast cancer (eBC)\n* Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive\n* Documented HER2- tumor according to ASCO\u002FCAP\n* Postmenopausal females at the time of signing the Informed Consent Form\n* Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months\n* Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent\n* Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment\n* Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance\n* Participant and investigator planning the first switch from an AI\n* Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and\u002For axillary lymph nodes dissection (ALND) and\u002For sentinel lymph node biopsy (SLNB) and\u002For radiotherapy\n* Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1\n\nExclusion Criteria:\n\n* Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents\n* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease\n* Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)\n* Have active cardiac disease or history of cardiac dysfunction\n* Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \\[HBV\\] or hepatitis C virus \\[HCV\\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis\n* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment\n* Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study",{"count":93,"type":23},300,[26],"The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.",[29],[98,99,100,101],"Estrogen receptor positive","ER+","Human epidermal growth factor receptor 2 negative","HER2-","2026-06-18",{"date":75,"type":44},{"date":77,"type":23},{"date":106,"type":23},"2034-06-30",{"name":108,"class":51},"Genentech, Inc.",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":60,"minAge":116,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":24,"phases":119,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100640407","refusal-of-sentinel-lymph-node-biopsy-in-patients-with-luminal-a-subtype-early-breast-cancer-100640407","NCT07579286","Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer","LumiNOde","Inclusion Criteria:\n\n1. HER2-negative breast cancer (ER +\u002F PR +), Ki67 \\\u003C= 30%, G1-2\n2. age\\> 59 years.\n3. morphologically confirmed diagnosis of breast cancer, IA-IIA stage\n4. ECOG score 0-2.\n5. the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).\n6. patient is able to provide informed consent and sign approved consent forms to participate in the study.\n7. patients after surgical treatment in the scope of breast resection with sentinel lymph node biopsy (SLNB, group 1) or without axillary surgery (without SLNB, group 2).\n8. N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.\n\nExclusion Criteria:\n\n1. Inconsistency with inclusion criteria.\n2. stage T2-4, N1 or M1 cancer\n3. severe uncontrolled concomitant chronic diseases or acute diseases\n4. previous\u002Fconcurrent malignancy or history of radiation therapy to the chest wall region\n5. any condition that is a contraindication to radiation therapy\n\n5\\. pregnancy","60 Years",{"count":118,"type":23},100,[120],"NA","Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer.\n\nThe main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer.",[29],[124,125,126,127,128,129],"early breast cancer","radiotherapy","refusal of Sentinel Lymph Node Biopsy","SLNB","breast surgery","Mammolymphoscintigraphy","2026-05-06",{"date":132,"type":44},"2026-05-12",{"date":134,"type":44},"2023-07-27",{"date":136,"type":23},"2027-05-25",{"name":138,"class":84},"N.N. Petrov National Medical Research Center of Oncology",1,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100634502","a-real-world-study-on-the-impact-of-different-adjuvant-treatment-regimens-on-prognosis-in-non-pcr-patients-with-her2-positive-breast-cancer-after-neoadjuvant-therapy-100634502","NCT07540520","A Real-World Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy","Retrospective Real-World Cohort Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy","Inclusion Criteria:\n\n* Histopathologically confirmed HER2-positive breast cancer (i.e., immunohistochemistry (IHC) staining result of 3+, or HER-2 2+ with fluorescence in situ hybridization showing HER-2 gene amplification);\n* Received neoadjuvant therapy with chemotherapy combined with trastuzumab before surgery: including at least 6 cycles of chemotherapy, with at least 4 cycles of taxane-based chemotherapy; and at least 4 cycles of trastuzumab treatment (including trastuzumab biosimilars and subcutaneous formulations);\n* Completion of radical surgery, postoperative pathology confirms the presence of invasive carcinoma in the breast and\u002For axillary lymph nodes after neoadjuvant therapy.\n* Hormone receptor status is known.\n\nExclusion Criteria:\n\n* Combine other systemic malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;\n* Stage IV metastatic breast cancer;\n* Incomplete clinical pathology and follow-up data; Study endpoints",{"count":148,"type":23},2000,"OBSERVATIONAL","This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.",[29],"2026-04-14",{"date":154,"type":44},"2026-04-20",{"date":156,"type":23},"2026-08-02",{"date":158,"type":23},"2026-12-31",{"name":160,"class":84},"Hebei Medical University Fourth Hospital",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":60,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":24,"phases":173,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100601141","phase-3-optimising-adjuvant-chemotherapy-prescription-in-young-patients-with-hormone-dependent-breast-cancer-using-genomic-tests-100601141","NCT07106632","Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests","Optimal Personalized Treatment of Early Breast Cancer Using Multi-parameter Analysis: Focus on YOUNGer Women","OPTIMA-YOUNG","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;\n2. . Premenopausal defined by patient that are not post-menopaused\n3. Female\n4. Age ≥ 35 years\n5. Diagnosis of invasive HR-positive (ER≥10% of tumour cells stained positive and any PR expression) HER2-negative (IHC score 0-1+ or 2+ with negative\u002Fnon-amplified ISH) invasive breast cancer; ER and HER2 determination will be assessed according to latest ASCO\u002FCAP or national guidelines;\n6. Breast and axillary surgery completed ≤ 12 weeks from study entry and randomization;\n7. Availability of a Formalin-Fixed Paraffin-Embedded (FFPE) tumour sample from surgery to perform Prosigna® analysis or slides.\n\n   Note: in case of receipt of neoadjuvant endocrine therapy the Prosigna® test must be done on the baseline biopsy. Performing the test on the surgical piece or on on-treatment biopsy is not permitted.\n8. Tumour size and axillary lymph node status. One of the following must apply:\n\n   1. 1-3 lymph nodes involved AND any invasive tumour size.\n   2. node negative (including micrometastases in at least 1 node \\[i.e. deposit \\>0.2-2mm diameter\\]) AND invasive tumour size ≥ 50mm.\n9. Multiple ipsilateral breast cancers are permitted provided that at least one tumour meets the tumour size and axillary lymph node entry criteria, and none meet any of the exclusion criteria.\n10. Bilateral breast cancers are permitted provided the tumour(s) in one breast meets the eligibility criteria and the other, contralateral tumour is not ER negative and\u002For HER2 positive and not clinically significant, defined by both of the following:\n\n    1. The contralateral tumour does not fulfil the tumour size and lymph node eligibility criteria required for trial entry; i.e. the following are not acceptable:\n\n       .i. presence of lymph node macro-metastases; .ii. tumour size ≥50mm when there is no lymph node involvement.\n    2. The treating physician does not consider that the characteristics of the contralateral tumour alone justify consideration of adjuvant chemotherapy.\n11. Fitness to receive adjuvant chemotherapy, as judged by the treating physician;\n12. Short term pre-surgical treatment with endocrine therapy, including in combination with non-cytotoxic agents, is allowed providing that the duration of treatment did not exceed 8 weeks;\n13. Patients affiliated with or a beneficiary of the local social security system, health social security system, or other local regulatory requirements\n14. Patients must agree to use adequate contraception methods for the duration of study treatment and for the duration specified in the SmPC after completing the treatment, unless agreed with the treatment physician the safety of attempt a pregnancy, which could be possible after at least 18 months of endocrine therapy.\n\nNote : patient with extracapsular nodular transgression are eligible. NOTE: If neoadjuvant endocrine therapy was received, the Prosigna® test must be realized on the baseline biopsy. Performing the test on the surgical specimen or on biopsy taken during treatment is not permitted.\n\nNOTE: Re-excision or complementary mastectomy for close\u002Fpositive surgical margins should be postponed after chemotherapy completion, if chemotherapy is given; breast reconstruction is allowed after trial entry.\n\nNOTE: The use of approved adjuvant targeted agents (abemaciclib, ribociclib and olaparib) combined to adjuvant endocrine therapy is allowed according to local practice recommendations and availability.\n\nExclusion Criteria:\n\n* 1\\. Postmenopausal women. Women who fulfil the following criteria at trial entry will be considered postmenopausal:\n\n  1. Age \\>45 and natural amenorrhoea of at least 1 year's duration.\n  2. Bilateral surgical oophorectomy.\n  3. For amenorrhoea not fulfilling the above criteria the diagnosis of postmenopausal status should be supported by hormone measurement: FSH levels must be \\> 25IU\u002FL with low oestradiol (i.e. within the locally defined postmenopausal range), in the event of doubt measured on 2 occasions preferably 4-6 weeks apart. This applies to women who have undergone hysterectomy without bilateral surgical oophorectomy and are age \\\u003C60; those ≥60 may be considered postmenopausal.\n\n     NOTE: Hormonal contraception will suppress FSH and oestradiol levels. In those taking oral contraception, levels will recover rapidly on discontinuation. Depo-Provera injectable contraception lasts many months: all women receiving this agent should be considered premenopausal.\n\n     2\\. Stage IV breast cancer; 3. Start of adjuvant systemic treatment (except for neoadjuvant endocrine therapy for a duration ≤ 8 weeks) before trial entry\\*; 4. Previous diagnosis of malignancy except:\n\n  \u003C!-- -->\n\n  1. Previous ductal carcinoma in situ (DCIS) or pleomorphic lobular carcinoma in situ (LCIS) of the breast managed by local treatment only;\n  2. Previous in situ carcinoma as defined by the International Classification of Diseases for Oncology (ICD-O) including basal cell carcinoma of skin and cervical intraepithelial neoplasia;\n  3. Previous invasive malignancy managed by local treatment only AND disease-free for at least 10 years.\n\n     5\\. Patients enrolled in another therapeutic trial within 30 days of inclusion; 6. Presence of concomitant medical and\u002For psychiatric comorbidities and\u002For social problems that might prevent informed consent, treatment compliance or follow up; 7. Person deprived of their liberty or under protective custody or guardianship.\n\n     8\\. Pregnant women or women who are breast-feeding at inclusion. 9. Patients unwilling or unable to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures because of geographic, familial, social, or psychological reasons.\n\n     \\*Trial entry is dated from of the date the participant signs the consent form or provides remote verbal consent, whichever is earlier.","35 Years","45 Years",{"count":172,"type":23},3380,[26],"Rationale:\n\nAround 70 to 80% of breast cancers are so-called \"hormone-dependent\" (HR+)\u002FHER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug associated with ovarian suppression (OFS), improve survival in patients with these cancers, which are characterised by a high risk of relapse. However, younger patients suffer more side effects than older women, particularly from chemotherapy. This can affect their quality of life and reduce their ability to work.\n\nFor post-menopausal women, genetic tests exist to assess whether chemotherapy is really necessary in addition to hormonal treatment. However, for high-risk premenopausal patients, chemotherapy is still systematically recommended, as no study has proved that it can be safely avoided. Clinical trials based on risk stratification using genetic tests have not been conclusive, but the majority of premenopausal women included had not received optimal hormone treatment. It is possible that the beneficial effect of chemotherapy is partly due to the artificial menopause it induces. Some experts believe that, for patients with a high clinical risk but a low genetic risk, an optimised hormonal treatment (drug + OFS) could suffice, without the need for chemotherapy.\n\nObjectives:\n\nMain objective: The aim of the study is to determine whether the use of a genetic test (Prosigna®) to decide whether or not to administer chemotherapy produces results as good as standard treatment (systematic chemotherapy) in premenopausal women with hormone-dependent (HR+) breast cancer\u002FHER2-, by assessing their risk of cancer recurrence.\n\nThe secondary objectives include verifying whether, in patients with a low Prosigna® score (around 70% of cases), optimised hormonal treatment (including suppression of ovarian function) is as effective as chemotherapy combined with hormonal in treatment preventing cancer recurrence. The study also seeks to compare the efficacy of treatment Prosigna®-guided versus systematic chemotherapy in terms of recurrence and quality of life, as well as economic aspects. Finally, the aim is to understand patients' concerns about the concept of reducing treatment (therapeutic de-escalation) and the way in which this information is communicated to them.\n\nThe primary endpoint of the study is to measure the time elapsed between the start of participation in the study and the appearance of an event indicating a return of the cancer. This includes the return of cancer in the same breast or neighbouring areas, the spread of cancer to other parts of the body, the appearance of new cancer in the other breast or death from any cause.\n\nTrial Population:\n\nThe study includes women major premenopausal diagnosed with invasive, hormone receptor-positive (ER+) and HER2-negative breast cancer. Patients must have undergone breast and axillary surgery recent and have a tumour sample suitable for analysis by the testProsigna® . They must be able to receive the study treatments Postmenopausal women, women with stage IV breast cancer, women who have already received adjuvant systemic treatment (except short neoadjuvant hormone therapy), women with a recent history of invasive cancer, pregnant women or women who are breast-feeding will not be able to take part in the study.\n\nInterventions:\n\nAfter agreeing to take part, patients will enter the pre-inclusion period (up to 28 days before randomisation), during which the investigator will carry out all the necessary tests to assess their eligibility. The investigator will then randomise the patients to find out which treatment they have been assigned, no more than 2 weeks later: the experimental group will receive a treatment decided on the basis of the results of a genomic test: either chemotherapy and hormone therapy, or hormone therapy alone. The control group will receive the standard treatment. The treatment and follow-up phases are the same as for standard care. Information on the quality of life patient's will and other information (associated costs, perception of their participation in the study, etc.) also be collected by means of questionnaires completed by the patients during the 5 years following randomisation.",[29,176,177],"Premenopausal Breast Cancer","HR+\u002FHER2- Breast Cancer",[179,180,181,182,183],"Adjuvant therapy de-intensification","Care delivery","Quality of Life","Premenopausal Women","Risk stratification","2026-03-23",{"date":186,"type":44},"2026-03-24",{"date":188,"type":23},"2026-04-01",{"date":190,"type":23},"2038-08-15",{"name":192,"class":84},"UNICANCER",105,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":205,"conditions":206,"keywords":209,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":139},"100566072","adherence-to-aromatase-inhibitors--abemaciclib-treatment-in-patients-with-early-stage-her2-negative-breast-cancer-100566072","NCT06650423","Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer","ONCO-ADHER: Adherence to Treatment With Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage, Endocrine-dependent, HER2-negative Breast Cancer","ONCO-Adher","Inclusion Criteria:\n\n* Female,\n* Early HR+\u002FHER-2- BC,\n* Patient is receiving adjuvant therapy with an aromatase inhibitor (letrozole, anastrozole or exemestane), with or without a CDK4\u002F6 inhibitor abemaciclib, for no more than 18 months,\n* Treatment of BC is being conducted at OIL,\n* Patient has mandatory health insurance through Health Insurance Institute of Slovenia,\n* Patient understands Slovenian language, and\n* Patient agrees to participate in the study and provides written informed consent.\n\nExclusion Criteria:\n\n* Metastatic HR+\u002FHER2-negative breast cancer\n* Previous treatment for breast cancer with an aromatase inhibitor, with or without a CDK4\u002F6 inhibitor, for early breast cancer prior to the current adjuvant treatment line","99 Years",{"count":204,"type":23},319,"Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+\u002FHER2-). Despite advancements in adjuvant endocrine therapy, 20-30% of early-stage breast cancer patients relapse within the first decade post-surgery. A recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 4\u002F6 inhibitors (CDK4\u002F6 inhibitors). Abemaciclib and ribociclib were assessed in the adjuvant setting, both showing improvement in invasive disease-free survival (IDFS). Abemaciclib has been approved by the FDA and EMA for HR+\u002FHER2- early breast cancer at high risk of disease recurrence and is the first addition to the Slovenian treatment regimen in routine clinical practice.\n\nPoor medication adherence can directly affect the effectiveness of treatment for early HR+\u002FHER2- breast cancer. While adherence data in patients treated with aromatase inhibitors are available, the adherence rate in patients with early HR+\u002FHER2- breast cancer taking abemaciclib remains unclear.\n\nIn this study, investigators hypothesize that patients receiving abemaciclib in combination with aromatase inhibitors will have lower medication adherence and higher discontinuation rates compared to those receiving aromatase inhibitors alone. It is expected that patients with better quality of life, better cognitive functioning, and a more positive attitude toward their therapy will demonstrate higher medication adherence rates. Adherence may also be influenced by additional factors, such as age and prior treatments.",[29,207,208],"Hormone Receptor Positive Tumor","HER2-negative Breast Cancer",[210,211,212,213,101,214,215,216],"breast cancer","medication adherence","CDK4\u002F6","HR+","aromatase inhibitor","quality of life","medication belief","2026-03-04",{"date":219,"type":44},"2026-03-06",{"date":221,"type":44},"2025-01-05",{"date":223,"type":23},"2027-03-01",{"name":225,"class":84},"Institute of Oncology Ljubljana",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":236,"conditions":237,"keywords":243,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":253,"locationsCount":139},"100627064","evaluation-of-adherence-to-cell-cycle-inhibitors-used-as-adjuvant-therapy-in-patients-with-localized-breast-cancer-at-high-risk-of-recurrence-100627064","NCT07443774","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence.","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence","AdheRA","Inclusion Criteria\n\n* Male or female patients aged ≥18 years.\n* Operable invasive breast carcinoma of no special type, hormone receptor-positive \u002F HER2-negative (estrogen receptor expression \\>10% with or without progesterone receptor expression \\>10%; HER2-negative defined as score 0, 1+, or 2+ non-amplified).\n* M0 disease according to the TNM 2018 classification.\n* Having undergone curative surgery of the primary breast tumor.\n* Having received adjuvant radiotherapy, if indicated.\n* Indication for combined adjuvant endocrine therapy and iCDK4\u002F6 therapy validated during a multidisciplinary tumor board meeting.\n* Initiation of adjuvant endocrine therapy combined with a CDK4\u002F6 inhibitor between June 2023 and June 2028.\n* No objection to participation in the study.\n* Affiliation with the national health insurance system.\n\nNon-Inclusion Criteria\n\n* Medical, geographical, sociological, psychological, or legal conditions that could prevent the patient from completing the study or from providing informed non-opposition.\n* Locally advanced, non-operable disease or metastatic disease not amenable to curative-intent treatment",{"count":235,"type":23},81,"Hormone receptor-positive (HR+) breast cancers represent the most common histological subtype of breast cancer, accounting for approximately 75% of cases, regardless of HER2 (human epidermal growth factor receptor 2) status (1). Adjuvant endocrine therapy (ET), including tamoxifen and aromatase inhibitors (AIs), is an effective pharmacological treatment for improving the prognosis of HR+ breast cancer, reducing the risk of recurrence by up to 50% (2-3-4-6). Despite its proven prognostic benefit, the full potential of endocrine therapy is not realized due to patient non-adherence (i.e., failure to comply with prescribed treatment). Adjuvant endocrine therapy is generally prescribed for a duration of 5 to 10 years. However, up to 40% of patients discontinue treatment prematurely, and 30% take the medication less frequently than prescribed. Poor adherence and low treatment persistence carry a substantial mortality burden: non-adherence is associated with a 49% increase in all-cause mortality. A retrospective analysis of a large database including more than 8,700 patients showed a 10-year survival rate of 80.7% among women who continued treatment, compared with 73.6% among those who discontinued adjuvant therapy prematurely (p \\\u003C 0.001). Among patients who continued treatment, the survival rate was 82% in those who were fully adherent, versus 78% in those who were only partially adherent (7-16).\n\nThe literature has documented a wide range of risk factors associated with non-adherence to or discontinuation of long-term adjuvant endocrine therapy. Treatment-related adverse effects, including hot flashes, joint stiffness, and sexual dysfunction, are common and may lead to treatment discontinuation. Fear of side effects may also prevent some patients from initiating or maintaining endocrine therapy. Others may not be fully convinced of the necessity of adjuvant endocrine therapy, particularly in the absence of overt signs of cancer. In addition, supportive care required to manage side effects is often inadequately reimbursed, making low income-combined with broader socioeconomic factors-a potential barrier to optimal adherence. Some patients may also experience difficulties remembering to take their medication regularly. The relative importance and contribution of these factors to non-adherence may evolve over time. Other factors may also play a role, including sociodemographic characteristics (low income, living alone, or unemployment).\n\nNevertheless, a residual risk of recurrence persists after five years of well-conducted standard endocrine therapy, extending up to two decades after diagnosis, particularly in patients with early-stage breast cancer stages II and III. In this higher-risk population, two phase III trials, monarchE and NATALEE, have recently evaluated the addition of a cell cycle inhibitor (CDK4\u002F6 inhibitor) to standard adjuvant endocrine therapy and reported positive results with a reduction in the risk of relapse.\n\nIn the NATALEE trial, quality of life was assessed in all patients in the ribociclib plus aromatase inhibitor group (n = 2,549) versus the aromatase inhibitor alone group (n = 2,552). Mean scores did not differ significantly from baseline for any of the analyzed domains. Similarly, no significant change from baseline was observed in either treatment group.\n\nHowever, it is important to note that 33.8% of patients discontinued ribociclib and 20% discontinued both endocrine therapy and ribociclib in the NATALEE trial, which is consistent with data from the literature.\n\nIn the monarchE trial, 16.6% of patients discontinued abemaciclib, and 6% discontinued both abemaciclib and endocrine therapy, while only 0.8% discontinued endocrine therapy in the control group. These findings are not consistent with previously published data.\n\nTo our knowledge, no real-world study has evaluated CDK4\u002F6 inhibitors in combination with endocrine therapy in the adjuvant treatment of HR+\u002FHER2-negative breast cancer.\n\nAdheRA is a prospective multicenter cohort study of patients with early-stage HR+\u002FHER2-negative breast cancer at high risk of recurrence, eligible for a combination of endocrine therapy and a CDK4\u002F6 inhibitor such as abemaciclib or ribociclib in the adjuvant setting, aiming to assess treatment adherence and the reasons for non-adherence.",[238,239,29,240,241,242],"ER+ Breast Cancer","Breast Cancer","Endocrine Therapy","Abemaciclib","Ribociclib",[124,244,245,246],"celle cycle inhibitors","endocrine therapy","adjuvant setting","2026-02-26",{"date":249,"type":44},"2026-03-02",{"date":188,"type":23},{"date":252,"type":23},"2031-12",{"name":254,"class":84},"University Hospital, Grenoble",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":24,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":139},"100610926","breast-cancer-organelle-properties-and-protein-expression-atlas-in-the-three-immunohistochemical-subtypes-of-breast-cancers-100610926","NCT07233928","Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers","ESPRESSOBREAST","* Inclusion Criteria:\n\n  1. Patient (women or men) with histologically documented breast cancer\n  2. Early Breast Cancer (eBC) or de novo metastatic BC (dnMBC), regardless the immunohistochemical subtype: Triple Negative BC (ER-negative \\[\\\u003C10%\\], PR-negative \\[\\\u003C10%\\] and HER2-negative \\[i.e. null, ultra-low or low\\] BC); HER2-positive BC: HER2 overexpression score 3+ or ERBB2 amplification whatever ER\u002FPR expression and proliferation level; Luminal A-like BC: low to moderately proliferative (Ki67\\\u003C20%) ER-positive (≥ 10%) PR-positive (≥ 20%) BC and low proliferative (Ki67\\\u003C 14%) ER-positive PR-negative (\\\u003C 20%) BC; Luminal B-like BC: highly proliferative (Ki67≥ 20%) ER-positive, PR-positive BC or moderately proliferative (14% ≤ Ki67\\\u003C 20%) ER-positive PR-negative (\\\u003C20%) BC\n  3. Age ≥ 18 years at the time of study entry\n  4. Patient followed within a standard of care procedure or clinical trial\n  5. ECOG performance status ≤ 2\n  6. Breast cancer treatment not yet started\n  7. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n  8. Patient affiliated to a Social Health Insurance in France.\n* Exclusion Criteria:\n\n  1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus.\n  2. Abnormal coagulation contraindicating biopsy\n  3. Previous or on going treatment for the breast cancer\n  4. Bone metastases when this is the only site of biopsiable disease for dnMBC patients\n  5. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin \\\u003C 8g\u002Fdl)\n  6. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n  7. Patient pregnant, or breast-feeding\n  8. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n  9. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":263,"type":23},1050,[120],"This trial is a translational, open-label, monocentric and prospective cohort study of participants with breast cancer aiming to create a combined ESPRESSO (= organelle properties) phenotype and spatial proteomics data collection encompassing four cohorts:\n\n* TN eBC = cohort A,\n* HER2+ eBC = cohort B,\n* Luminal eBC = cohort C,\n* dnMBC = cohort D. In total 1050 participants will be enrolled in the study. Laboratory analysis (including ESPRESSO technique) will be conducted on the biological specimen collected during this study.\n\nThe primary objective is to describe the amount of fatty acids accumulated in lipid droplets, within the four cohorts. As a secondary objective, the analysis will expand to other organelles like lysosomal acidity and nuclear organization.\n\nThe study is due to last 9 years (4 years of recruitment and 5 years of study participation)",[29,267],"Metastatic Breast Cancer",[210,269,270,271,272],"organelle","lipid droplets","protein expression atlas and heterogeneity","metabolism","2026-02-09",{"date":275,"type":44},"2026-02-10",{"date":277,"type":44},"2026-02-06",{"date":279,"type":23},"2035-02-06",{"name":281,"class":84},"Institut Claudius Regaud",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":18,"minAge":288,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":24,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100624153","evaluation-of-the-effectiveness-of-managing-chemotherapy-side-effects-using-epro-and-a-standardized-telenursing-program-for-cancer-patients-100624153","NCT07405931","Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Diagnosed with early or advanced gastric, lung, breast, or colon cancer\n* Starting first-cycle chemotherapy with a new anticancer agent\n* Able to use a smartphone without difficulty\n* Willing to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Individuals who have difficulty communicating due to cognitive impairment, visual impairment, hearing impairment, or other reasons\n* Individuals who cannot read, write, or understand Korean\n* Other individuals deemed inappropriate for participation by the investigators","19 Years",{"count":290,"type":23},414,[120],"This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and self-manage chemotherapy-related adverse effects.",[294,295,296,297,29,298,299,300],"Early Gastric Cancer","Advanced Gastric Cancer","Early Lung Cancer","Advanced Lung Cancer","Advanced Breast Cancer","Early Colon Cancer","Advanced Colon Cancer","2026-02-08",{"date":303,"type":44},"2026-02-12",{"date":305,"type":44},"2025-07-09",{"date":307,"type":23},"2026-09",{"name":309,"class":84},"Ulsan University Hospital",5,{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":319,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":24,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100593494","phase-2-mediterranean-diet-and-inequality-in-early-breast-cancer-100593494","NCT07007169","Mediterranean Diet and Inequality in Early Breast Cancer","Mediterranean Diet and Inequality in Early Breast Cancer: A Multicenter Randomized Clinical Trial","MEDITERRACARE","Inclusion Criteria:\n\n1. Signed written informed consent approved by the Ethical Review Board.\n2. Age ≥ 18\n3. Histologically confirmed unilateral adenocarcinoma of the breast, stage I-III, candidates for neoadjuvant chemotherapy followed by curative surgery, or adjuvant chemotherapy after curative surgery, according to the Danish Breast Cancer Group guidelines 48. The addition of trastuzumab and pertuzumab in HER2-positive tumors, or pembrolizumab in triple-negative tumors, per Danish Breast Cancer Group guidelines 48, is allowed as an adjunct to chemotherapy.\n4. Good performance status (WHO performance status 0 or 1).\n5. Willingness by the patient to undergo treatment and study-related procedures according to the protocol.\n6. Have a smartphone or computer to which it is possible to receive emails (for food diary; www.myfood24.org)\n7. Must be willing to restrict from probiotic (living microorganisms) supplements during the study. Fermented foods are allowed.\n\n   \\-\n\nExclusion Criteria:\n\n1. Clinical or radiological signs of metastatic disease.\n2. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer.\n3. Previous chemotherapy for cancer or other malignant disease.\n4. Major altered digestive system disorders (e.g. gastric by-pass or Crohn's disease or ulcerative colitis)\n5. Unable to communicate effectively in Danish or English.",true,{"count":193,"type":23},[64],"Social determinants such as education, income, marital status, and social networks play a crucial role in cancer outcomes, including breast cancer. One potential influencing factor is diet, and the Mediterranean diet has been shown to benefit both the health and the microbiome.\n\nThis raises the question: Does adherence to the Mediterranean diet impact the microbiome, quality of life, overall well-being, and outcomes in breast cancer patients undergoing (neo)adjuvant treatment, particularly among those with unfavorable socioeconomic determinants?\n\nThe Mediterranean diet consists of plant foods such as vegetables, fruits, nuts, seeds, berries, legumes, herbs, and spices. It also features animal proteins like fish, meat, and cheese, along with fat from olive oil. Thus, adherence to the Mediterranean diet is adherence to the official Danish diet recommendations.\n\nThis phase II clinical trial is an interdisciplinary study combining nutrition, sociology, and health research. Breast cancer patients candidates for (neo)adjuvant treatment at four oncology departments in Region South Denmark will be randomized 2:1 to the Mediterranean diet (with individual dietary guidance from a nutrition therapist aiming at daily consumption of a minimum of 30 grams of dietary fiber and weekly consumption of a minimum of 30 different plant foods; minimizing the amount of ultra-processed food) versus the patient's regular diet, in conjuction with the (neo)adjuvant chemotherapy.\n\nThe trial's primary endpoint will be changes in gut microbiota composition in feces.\n\nThe study evaluates how the Mediterranean diet affects the microbiota (evaluated using Oxford Nanopore Technology 16S sequencing on fecal samples); short-chain fatty acids in stool and plasma (assessed by mass spectrometry); immune system (using flow cytometry for immune cell determination in blood and immunohistochemical determination of immune cells in the tumor tissue); and patients' social quality of life, overall well-being, sense of empowerment, and personal feeling of agency (using the WHOQOL-100 questionnaire); taking into account the impact of the distance from the patient residence to the hospital (tracked from GEOTEAM at Statistics Denmark), and socioeconomic factors (using the DREAM database).\n\nThe evaluation of biological parameters is based on the suggested mechanism of action. A diet rich in various plant foods and dietary fiber will alter the gut microbiota, promoting bacteria producing high amounts of short-chain fatty acids. These fatty acids will activate immune cells, aiding in the destruction of cancer cells.\n\nThe study will also assess whether the Mediterranean diet will positively impact the patients' social quality of life, overall well-being, sense of empowerment, and personal feeling of agency. The Mediterranean diet may not only lead to improved dietary habits but also serve as a crucial tool for breast cancer patients, particularly among those with unfavorable socioeconomic determinants. Enhanced empowerment and improved coping tools could be an important step in combating cancer-related inequalities.",[29],[325,326,327,328,329,330,331],"Microbiome","Mediterranean Diet","Inequality in cancer","Chemotherapy","Adjuvant","Neoadjuvant","Short-chain Fatty Acids","2025-12-29",{"date":334,"type":44},"2026-01-02",{"date":336,"type":44},"2025-03-27",{"date":338,"type":23},"2036-03",{"name":340,"class":84},"Esbjerg Hospital - University Hospital of Southern Denmark",2,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":24,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":341},"100618084","phase-2-mri-guided-neoadjuvant-treatment-de-escalation-in-stage-ii-iii-tnbc-100618084","NCT07327021","MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC","NOGA: Neoadjuvant Treatment Optimization Via MRI-Guided De-Escalation in Stage II-III TNBC - A Phase 2 Study.","NOGA","Inclusion Criteria:\n\n* Patient is eligible per physician's discretion for the KEYNOTE-522 regimen (Neoadjuvant paclitaxel-carboplatin-doxorubicin-cyclophosphamide-pembrolizumab)\n* Signed written informed consent\n* Histologically confirmed primary infiltrating breast cancer with estrogen receptor expression \\\u003C1%, Progesterone receptor expression \\\u003C1%, and without overexpression and\u002For amplification of HER2 according to ASCO\u002FCAP 2013 guideline (locally assessed)\n* T2-3N0, T1-3N1 disease according to TNM-staging (8th edition, AJCC).\n* Nodal status must be examined by ultrasound and fine-needle aspiration or core biopsy in case of suspicious lymph nodes.\n* No evidence of distant metastases (Stage IV disease) on FDG-PET performed within 35 days of enrollment.\n* Age ≥18\n* WHO performance status ≤ 2\n* Visible breast tumor on contrast enhanced MRI (no minimal longest diameter required)\n* MRI breast must be performed within 35 days prior to registration\n* Patients with a history of autoimmune disease are eligible for the study per treating physician's discretion.\n* Laboratory requirements - within 21 days prior to enrollment:\n\n  * Adequate bone marrow function (ANC ≥1.5 x 109\u002Fl, platelets ≥100 x 109\u002Fl)\n  * Adequate hepatic function (ALT, AST and bilirubin ≤2.5 times upper limit of normal)\n  * Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists;\n  * Adequate renal function: creatinine clearance \\>50 ml\u002Fmin estimated using the Cockcroft-Gault equation, or based on a 24-hour urine collection measurement\n  * LVEF ≥50% measured by echocardiography\n* Women of childbearing potential and men must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods (failure rate of \\\u003C1% per year,) during treatment and for at least 6 months after the last dose of pembrolizumab. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative β-HCG serum or urine pregnancy test result.\n\nExclusion Criteria:\n\n* Concurrent breastfeeding\n* Concurrent contralateral or ipsilateral non-TNBC second primary infiltrating breast cancer. Contralateral or ipsilateral TNBC second primary infiltrating breast cancer or DCIS is allowed.\n* Concurrent anti-cancer treatment or another investigational drug\n* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Patients who have a history of a second malignancy are eligible, provided the malignancy has been adequately treated, there is no ongoing treatment for the second malignancy, and overall principal investigator (PI) approval is obtained.\n* Has undergone excisional biopsy of the primary tumor, and\u002For axillary lymph node dissection prior to study treatment.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.",{"count":351,"type":23},54,[64],"Breast cancer is the most common malignancy among women worldwide. Triple-negative breast cancer (TNBC), defined by the lack of estrogen receptor, progesterone receptor, and HER2 expression, comprises approximately 15% of all breast cancers and is the most aggressive subtype, associated with a higher risk of early recurrence and death compared to other breast cancer subtypes. Neoadjuvant chemotherapy (NACT), administered before definitive surgery, is the standard of care for stage II-III TNBC (eTNBC), and pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes at surgery, following neoadjuvant systemic therapy, is strongly associated with improved survival in this population.\n\nIn the pivotal phase 3 KEYNOTE-522 study, the addition of Pembrolizumab (an immune checkpoint inhibitor (ICI), a PD-1 inhibitor) to NACT significantly improved both pCR rates and survival in patients with eTNBC , establishing a new standard of care for these patients. The KEYNOTE-522 regimen is a five-drug regimen administered in two distinct phases: in the first phase, Paclitaxel and Carboplatin are administered with Pembrolizumab for four cycles (TCa+P) and in the second phase, Adriamycin and Cyclophosphamide are administered with Pembrolizumab for an additional four cycles (AC+P). This regimen carries a high toxicity burden, particularly due to anthracyclines, which are associated with late cardiotoxicity and increased risk of therapy-related leukemias.\n\nMany patients, however, achieve an excellent response after only the first phase of treatment (paclitaxel-carboplatin + pembrolizumab), raising the question of whether treatment can be safely de-escalated in selected responders. Emerging evidence from the NeoPACT and NEO-N studies suggests that pCR rates of 55-58% can be achieved with taxane-carboplatin-pembrolizumab regimen, even in the absence of anthracyclines. Moreover, the recently published TRAIN-3 study in HER2+ breast cancer demonstrated that radiologic complete response on MRI (MRI-CR) strongly correlates with pCR in hormone receptor-negative disease, with 87% concordance.\n\nBuilding on this rationale, we propose a prospective, investigator-initiated, multicenter, phase II clinical trial in Israel to evaluate the feasibility and efficacy of MRI-guided de-escalation of NACT plus immunotherapy in patients with eTNBC. All enrolled patients will receive four cycles (12 weeks) of paclitaxel-carboplatin with pembrolizumab (TCa+P), followed by breast MRI to assess treatment response. Patients achieving MRI-CR will proceed directly to surgery, omitting the second phase of anthracycline-containing chemotherapy (AC+P). Patients with radiologic residual disease (MRI-RD) will complete the full KEYNOTE-522 regimen. Adjuvant therapy, including pembrolizumab continuation and\u002For additional chemotherapy, will be administered based on pathological findings and physician and patient discretion.\n\nThe primary endpoint is pCR rate among patients who achieve MRI-CR and undergo early surgery. The trial uses a Simon's two-stage optimal design and aims to test whether the observed pCR rate in MRI-CR patients exceeds the benchmark of 65% (based on KEYNOTE-522), with a target of 87% as suggested by TRAIN-3. Based on this approach, to reject the null hypothesis, a pathologic complete response (pCR) must be achieved in at least 22 of the 27 patients with MRI-CR who are referred to early surgery. Overall, Approximately 54 patients will be enrolled in the study to reach this goal. Key secondary endpoints include recurrence-free survival (RFS), overall survival (OS), and patient-reported quality of life (QoL). Patient-reported outcomes (PROs) will be collected longitudinally throughout the study to assess physical symptoms, psychological well-being, treatment-related toxicities, and functional recovery, helping to evaluate how treatment de-escalation impacts patient's experience.\n\nIn addition, the study will prospectively collect blood samples for circulating tumor DNA (ctDNA) analysis, creating a unique biorepository of biologic material for translational research. ctDNA dynamics will be evaluated as a complementary biomarker to MRI, enabling assessment of early treatment response, molecular residual disease, and mechanisms of resistance. Samples will be collected at multiple timepoints, before treatment, during therapy, and prior to surgery, providing a rich dataset for future genomic, epigenetic, and immune profiling studies.\n\nThis study represents an innovative, precision-driven approach to treatment de-escalation in eTNBC, with the potential to influence clinical practice and redefine the standard of care by identifying patients who can safely avoid anthracycline-based chemotherapy without compromising efficacy.",[355,29],"TNBC, Triple Negative Breast Cancer",[357,358,359],"TNBC","KEYNOTE-522","MRI","2025-12-24",{"date":362,"type":44},"2026-01-08",{"date":364,"type":44},"2025-11-11",{"date":366,"type":23},"2030-11-01",{"name":368,"class":369},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":390,"locationsCount":139},"100616767","this-clinical-trial-is-a-retrospective-multicenter-cohort-study-evaluating-the-real-world-characteristics-and-risk-of-disease-recurrence-in-hormone-receptor-positive-her2-negative-early-breast-cancer-100616767","NCT07309887","This Clinical Trial is a Retrospective, Multicenter Cohort Study Evaluating the Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer.","Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer: a Multi-center Retrospective Cohort Study in Korea","PRIORITY","Inclusion Criteria:\n\n1. Patients (female or male) with a histologically confirmed first diagnosis of invasive breast cancer, identified by International Classification of Diseases, 10th Revision (ICD-10) code C50.x, between January 1, 2010, and December 31, 2023.\\* The date of diagnosis will be based on the initial pathology report or the date reported to the Korea Central Cancer Registry (KCCR).\n2. Age 18 years or older at the time of initial diagnosis.\n3. Anatomical stage I, II, or III disease at initial diagnosis, staged according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, using the edition contemporary to the time of diagnosis.\n4. Confirmed HR-positive disease, defined as estrogen receptor (ER) and\u002For progesterone receptor (PR) expression in ≥1% of invasive tumor cells on immunohistochemistry (IHC), or an Allred proportion score of 2 or higher.\n5. Confirmed HER2-negative disease, defined as an IHC score of 0 or 1+, or an IHC score of 2+ with a negative in situ hybridization (ISH) result (e.g., fluorescence in situ hybridization or silver in situ hybridization). Patients recorded as HER2-negative without a specific score available will also be included.\n6. Documented history of having received definitive (curative-intent) surgery for the primary breast cancer (e.g., breast-conserving surgery or mastectomy).\n\nExclusion Criteria:\n\n1. Patients (female or male) with a histologically confirmed first diagnosis of invasive breast cancer, identified by International Classification of Diseases, 10th Revision (ICD-10) code C50.x, between January 1, 2010, and December 31, 2023.\\* The date of diagnosis will be based on the initial pathology report or the date reported to the Korea Central Cancer Registry (KCCR).\n2. Age 18 years or older at the time of initial diagnosis.\n3. Anatomical stage I, II, or III disease at initial diagnosis, staged according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, using the edition contemporary to the time of diagnosis.\n4. Confirmed HR-positive disease, defined as estrogen receptor (ER) and\u002For progesterone receptor (PR) expression in ≥1% of invasive tumor cells on immunohistochemistry (IHC), or an Allred proportion score of 2 or higher.\n5. Confirmed HER2-negative disease, defined as an IHC score of 0 or 1+, or an IHC score of 2+ with a negative in situ hybridization (ISH) result (e.g., fluorescence in situ hybridization or silver in situ hybridization). Patients recorded as HER2-negative without a specific score available will also be included.\n6. Documented history of having received definitive (curative-intent) surgery for the primary breast cancer (e.g., breast-conserving surgery or mastectomy).",{"count":379,"type":23},100000,"* Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+\u002FHER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy.\n* Secondary objectives: Include assessment of relapse-free survival (RFS), distant disease-free survival (DDFS), distant relapse-free survival (DRFS), overall survival (OS), site of distant recurrence, and time-to-next treatment (TTNT), as well as evaluating the association between clinicopathologic\u002Ftreatment variables and clinical outcomes.\n* Key inclusion criteria: Adults (≥18 years) with stage I-III HR+\u002FHER2- invasive breast cancer who underwent curative surgery\n* Key exclusion criteria: HR- or HER2+ tumors, de novo stage IV, or lack of curative-intent surgery",[29],[383],"Early breast cancer retrospective cohort study","2025-12-16",{"date":386,"type":44},"2025-12-30",{"date":388,"type":23},"2025-12-17",{"date":158,"type":23},{"name":391,"class":84},"Samsung Medical Center",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":401,"briefSummary":402,"conditions":403,"keywords":408,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":4},"100616567","phase-2-shr-a1811-plus-pertuzumab-as-neoadjuvant-therapy-for-early-or-locally-advanced-hr-positive-her2-positive-breast-cancer-a-prospective-open-label-phase-ii-study-100616567","NCT07307287","SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study","Inclusion Criteria:\n\n1. Female, aged 18-70 years at the time of informed consent.\n2. Histologically confirmed invasive breast cancer, with no prior systemic anti-cancer therapy.\n3. Pathologically documented HR-positive (ER ≥ 1% and\u002For PR ≥ 1%) and HER2-positive disease, per the 2018 ASCO-CAP guidelines: IHC 3+ or IHC 2+ with ISH ratio ≥ 2.0.\n4. Clinical stage II-III (cT2-cT4 or cN+, cM0) per the 8th edition of the AJCC Cancer Staging Manual.\n5. At least one measurable lesion per RECIST v1.1 criteria.\n6. ECOG performance status 0-1.\n7. Estimated life expectancy of ≥ 12 months.\n8. Adequate organ function within 14 days prior to the first dose (without transfusion or growth factor support):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelets ≥ 100 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL\n   2. Albumin ≥ 3.0 g\u002FdL; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT)\u002Faspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (per Cockcroft-Gault formula)\n   3. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n   4. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography\n   5. Fridericia-corrected QT interval (QTcF) ≤ 470 ms\n9. Premenopausal women with reproductive potential must have a negative serum β-human chorionic gonadotropin (β-hCG) test within 7 days before treatment, use effective barrier contraception throughout the study period and for 6 months after the last dose, and not be breastfeeding.\n10. Provision of signed written informed consent; willingness to comply with all study visits and procedures.\n\nExclusion Criteria:\n\n1. Breast cancer not confirmed by histopathology.\n2. Bilateral, inflammatory, or occult breast cancer.\n3. Any prior anti-cancer therapy (chemotherapy, radiotherapy, targeted, endocrine, etc.); radical radiotherapy ≤ 4 weeks or palliative radiotherapy ≤ 2 weeks before first dose.\n4. Concomitant anti-cancer therapy of any kind.\n5. Other malignancies within 5 years (except cured basal-cell skin cancer or cervical carcinoma in situ).\n6. Participation in another drug trial ≤ 4 weeks before enrolment.\n7. Systemic immunosuppressive therapy (e.g., \\> 10 mg\u002Fday prednisone equivalent) ≤ 2 weeks before first dose (nasal\u002Finhaled corticosteroids allowed).\n8. Live or attenuated vaccines ≤ 4 weeks before first dose.\n9. Major non-breast surgery ≤ 4 weeks before first dose or not fully recovered.\n10. Active autoimmune disease or history of recurrent autoimmunity (e.g., autoimmune hepatitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyper\u002Fhypothyroidism except stable hormone replacement). Controlled vitiligo, psoriasis, alopecia, insulin-dependent type 1 diabetes, or childhood asthma in complete remission allowed. Asthma requiring bronchodilators excluded.\n11. Immunodeficiency (HIV positive, congenital\u002Fsecondary), prior organ transplant.\n12. Uncontrolled or significant cardiovascular\u002Fcerebrovascular disease, including within 6 months: NYHA III\u002FIV heart failure, MI, stroke (except lacunar), pulmonary embolism, unstable angina, significant arrhythmia; cardiomyopathies; QTc \\> 470 ms (Fridericia, female), 2nd\u002F3rd degree AV block, atrial fibrillation ≥ EHRA 2b, uncontrolled hypertension.\n13. Interstitial lung disease or any moderate-severe pulmonary disorder that may interfere with drug-related lung toxicity assessment: idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans, pulmonary embolism, severe asthma\u002FCOPD, restrictive\u002Fobstructive defects, autoimmune\u002Fconnective-tissue lung involvement, prior pneumonectomy.\n14. Active hepatitis B (HBsAg+ and HBV DNA ≥ 500 IU\u002FmL), hepatitis C (anti-HCV+ and HCV RNA \\> ULN), cirrhosis, or severe infection requiring antibiotics\u002Fantivirals\u002Fantifungals.\n15. Hereditary\u002Facquired bleeding or thrombotic diatheses (e.g., hemophilia, coagulopathy).\n16. Known hypersensitivity to study drugs or excipients.\n17. Pregnant or lactating women; women of child-bearing potential with positive baseline pregnancy test or unwilling to use effective contraception throughout the study.\n18. Any severe concomitant condition jeopardizing patient safety or compliance (e.g., uncontrolled hypertension, diabetes, active infection) or significant neurologic\u002Fpsychiatric disorder (epilepsy, dementia) that, in the investigator's opinion, renders","75 Years",{"count":400,"type":23},30,[64],"Breast cancer is the most common malignancy in women, with approximately 20% classified as HER2-positive. Anti-HER2 blockade (trastuzumab plus pertuzumab) combined with chemotherapy constitutes the standard neoadjuvant regimen; however, the pathological complete response (pCR) rate in the HR-positive subgroup remains only 35-40%, and platinum-containing schedules are associated with significant hematologic toxicity. Antibody-drug conjugates (ADCs) integrate targeted delivery with potent cytotoxic payloads. SHR-A1811 (ruikang-trastuzumab), a domestically developed ADC by Hengrui Pharmaceutical, is conjugated with a topoisomerase I inhibitor (mean drug-to-antibody ratio \\[DAR\\] ≈ 6). Preclinical data demonstrate that SHR-A1811 exhibits superior efficacy to trastuzumab emtansine (T-DM1) in both trastuzumab-sensitive and resistant HER2-expressing tumor models, with a manageable safety profile.\n\nThis prospective, open-label, phase II trial will enroll patients with early-stage\u002Flocally advanced HR-positive\u002FHER2-positive breast cancer, who will receive neoadjuvant SHR-A1811 plus pertuzumab. At baseline, BluePrint gene profiling will be performed to stratify participants into luminal and non-luminal subtypes: patients with luminal subtype who achieve stable disease (SD) after 4 cycles will switch to a regimen of trastuzumab, pyrotinib, dalpiciclib, and an aromatase inhibitor for an additional 4 cycles; all other patients will continue ADC-based dual-target therapy for 2-4 further cycles, followed by surgical resection. Circulating tumor DNA (ctDNA) dynamics will be dynamically monitored at baseline, after 4 cycles of treatment, and preoperatively to evaluate early treatment sensitivity.\n\nThe primary endpoint is the pCR rate. Secondary endpoints include event-free survival (EFS), objective response rate (ORR), and safety profiles. Exploratory analyses will investigate the correlation between molecular subtypes and treatment responses, aiming to establish a chemotherapy-free, precision neoadjuvant strategy for HR-positive\u002FHER2-positive breast cancer.",[404,405,406,29,407],"SHR-A1811","HER2-Postive Breast Cancer","HR+ Breast Cancer","Locally Advanced Breast Cancer",[404,405,406,29],"2025-12-14",{"date":332,"type":44},{"date":412,"type":23},"2025-12-20",{"date":414,"type":23},"2027-12-31",{"name":416,"class":84},"Tianjin Medical University Cancer Institute and Hospital",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":24,"phases":426,"briefSummary":427,"conditions":428,"keywords":435,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":139},"100615410","a-prospective-cohort-study-of-handx---assisted-endoscopic-mastectomy-feasibility-and-safety-athena-i-study-100615410","NCT07292246","A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)","ATHENA I","Inclusion Criteria:\n\n* Female sex\n* Age ≥ 18 years old\n* Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:\n\n  1. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery\n  2. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response\n  3. ductal carcinoma in situ (DCIS), or\n  4. BRCA or other breast cancer - related genetic mutation carriers, or\n  5. high risk for development of breast cancer.\n* Breast volume: cup sizes A to C as defined by underwear size, expected implant volume \\\u003C550cc and glandular ptosis not exceeding Grade I Regnault's classification.\n* ECOG \u002F WHO Performance Status \\\u003C2\n* Subject with signed and dated informed consent form\n\nExclusion Criteria:\n\n* Chest wall or skin invasion\n* Extended lymph node involvement at diagnosis (cN2)\n* Inflammatory breast cancer\n* Tumor distance from nipple - areola complex \\\u003C1cm on imaging studies\n* Active smoking\u002Fnicotine use within 4 weeks pre-op (combustible tobacco, vaping, nicotine pouches, NRT)\n* BMI \\>35\n* High risk patients with severe and poorly controlled co-morbid conditions (including but not limited to diabetes, heart disease, renal failure or liver dysfunction)\n* Pregnancy or breastfeeding\n* Psychiatric, addictive, or any disorders which compromise the ability to give informed consent for participation in this study\n* Subject without signed and dated informed consent form",{"count":425,"type":23},15,[120],"This study aims to learn whether a handheld robotic device, called the HandX, can help surgeons safely perform a minimally invasive nipple-sparing mastectomy. This type of mastectomy uses a small incision at the side of the breast to remove breast tissue while keeping the skin and nipple in place. The goal is to lower scarring, improve comfort, and support good cosmetic results after surgery.\n\nParticipants in this study will already be planning to have a therapeutic or preventive mastectomy with immediate implant-based reconstruction. All surgeries are done at Mediterraneo Hospital in Greece.\n\nDuring the operation, surgeons use the HandX device to assist with the endoscopic dissection. Researchers will collect information about how long the surgery takes, whether the planned approach can be completed without switching to open surgery, and whether any surgical complications occur. They will also check healing, infection, and implant-related problems for up to 365 days after surgery. Participants will complete the BREAST-Q questionnaire before surgery and at several times after surgery to share their views on comfort, well-being, and cosmetic outcomes.\n\nAbout 15 participants will take part. The results will help researchers understand whether this approach is practical and safe, and whether it should be studied further in a larger trial.",[239,429,430,431,432,433,434,29],"BRCA 1 Gene Mutation","BRCA 2 Gene Mutation","Hereditary Breast Carcinoma","Breast Neoplasms","DCIS","Germline Mutation Abnormality",[210,436,437,438,439,440],"mastectomy","endoscopic","robotic","handx","nipple-sparing mastectomy","2025-12-05",{"date":443,"type":44},"2025-12-18",{"date":445,"type":44},"2025-09-09",{"date":447,"type":23},"2029-10",{"name":449,"class":84},"Vasileios Kalles",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":24,"phases":459,"briefSummary":460,"conditions":461,"keywords":465,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":4},"100602874","phase-2-shr-a1811-for-her2-positive-breast-cancer-with-suboptimal-neoadjuvant-response-100602874","NCT07129187","SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response","An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response","Inclusion Criteria:\n\n* 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;\n* 2.Early or locally advanced HER2-positive invasive breast cancer;\n* 3.Known hormone receptor status;\n* 4.ECOG score of 0-1;\n* 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;\n* 6.Organ function levels must meet the following requirements:\n* 7.Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.\n* 8.The subjects voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer\n* 2\\. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention\n* 3\\. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history\n* 4\\. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)\n* 5\\. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)\n* 6\\. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases\n* 7\\. History of or planned administration of live attenuated vaccines within 28 days\n* 8\\. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis\n* 9\\. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year\n* 10\\. History of allogeneic bone marrow or solid organ transplantation\n* 11\\. Peripheral neuropathy of grade ≥ 2\n* 12\\. Severe heart diseases\n* 13\\. Receipt of systemic immunostimulant therapy within 4 weeks\n* 14\\. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)\n* 15\\. Allergy to study drugs\u002Fexcipients, or history of severe allergic reaction to other monoclonal antibodies\n* 16\\. Pregnant or lactating women; fertile women with positive pregnancy test or unwilling to take effective contraception throughout the trial\n* 17\\. History of neurological\u002Fpsychiatric disorders , or history of substance abuse, alcoholism, or drug addiction\n* 18\\. Other circumstances deemed unsuitable for enrollment by the researcher","70 Years",{"count":400,"type":23},[64],"This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.",[29,462,463,464],"HER2 + Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer",[466,467,404,468],"neoadjuvant therapy","antibody drug conjugate","suboptimal response","2025-08-20",{"date":471,"type":44},"2025-08-26",{"date":473,"type":23},"2025-10",{"date":475,"type":23},"2030-10",{"name":477,"class":84},"Chuan Wang",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":24,"phases":487,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":4},"100600720","phase-2-dalpiciclib-as-adjuvant-therapy-for-hr-positiveher2-negative-early-stage-patients-100600720","NCT07101159","Dalpiciclib as Adjuvant Therapy for HR-positive\u002FHER2-negative Early-stage Patients","Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy in Early-stage HR-positive\u002FHER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study","Inclusion Criteria:\n\n* Female breast cancer patients aged ≥ 18 years, who are postmenopausal or premenopausal\u002Fperimenopausal;\n* Histologically confirmed HR-positive, HER2-negative early-stage breast cancer (immunohistochemical detection shows ER ≥ 10% and\u002For PR ≥ 10%, HER2 0-1+ or HER2 ++ but negative and non-amplified by FISH or CISH detection);\n* Histologically confirmed invasive breast cancer with postoperative pathological stage II-III;\n* Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy are eligible for enrollment;\n* The maximum time from surgery to enrollment does not exceed 12 months;\n* Patients receiving radiotherapy must have recovered from acute radiation reactions, with a washout period of at least 14 days from the end of radiotherapy to enrollment;\n* Patients who received previous chemotherapy must have recovered from acute adverse reactions of chemotherapy (graded ≤ 1 according to \\[CTCAE\\]) before enrollment, except for alopecia or grade 2 peripheral neuropathy. There must be a washout period of at least 21 days from the last chemotherapy administration to enrollment;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* The main organ function levels must meet the following requirements: Blood routine: Neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; Platelet count (PLT) ≥ 90×10⁹\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL;Blood biochemistry: Total bilirubin (TBIL) ≤ 2.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×ULN; Alkaline phosphatase ≤ 2.5×ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5×ULN;\n* 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C 470 ms in females (QTcF calculation formula: QTcF = QT\u002F(RR\\^1\u002F3));\n* Voluntarily participate in this study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Stage IV breast cancer, recurrent or metastatic breast cancer, or inflammatory breast cancer;\n* A history of any malignant tumor, or having received anti-tumor treatment or radiotherapy for any malignant tumor in the past, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;\n* Concurrent participation in other clinical trials;\n* Having received blood transfusion or treatment with colony-stimulating factors, etc. within 2 weeks before enrollment;\n* Known history of allergy to the components of the drugs in this protocol;\n* History of immunodeficiency, including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;\n* A history of any heart disease, including: angina pectoris; arrhythmia requiring drug treatment or with clinical significance; myocardial infarction; heart failure; any other heart disease judged by the researcher as unsuitable for participating in this trial;\n* Pregnant or lactating female patients;\n* Any other conditions that the researcher deems make the subject unsuitable for participating in this study.",{"count":486,"type":23},200,[64],"This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.\n\nIt is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.\n\nThe primary endpoint is 3-year invasive disease-free survival (iDFS).",[29,490,491],"Adjuvant Therapy","Hormone Receptor Positive \u002F HER2-negative Breast Cancer",[493,494,124],"dalpiciclib","hormone receptor positive\u002FHER2-negative breast cancer","2025-08-01",{"date":497,"type":44},"2025-08-03",{"date":499,"type":23},"2025-09",{"date":252,"type":23},{"name":502,"class":369},"Fujian Cancer Hospital",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":60,"minAge":511,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":341},"100591732","hypofractionated-radiotherapy-with-concomitant-tumor-bed-boost-for-breast-cancer-100591732","NCT06984250","Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer","Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer","HFCBB","Inclusion Criteria:\n\n* Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS).\n* Patients undergoing breast-conserving surgery\n* Age ≥ 20 years\n* Karnofsky Performance Status (KPS) ≥70%\n* Life expectancy ≥ 5 years\n* Adequate renal and hepatic function\n\nExclusion Criteria:\n\n* Pregnant patients\n* Patients requiring re-irradiation of the thoracic region","20 Years","85 Years",{"count":514,"type":23},315,"Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy",[29,517],"Ductal Breast Carcinoma In Situ",[210,519,520,521,522],"concomitant boost","tumor bed","Intensity-modulated radiation therapy","hypofractionated breast radiotherapy","2025-05-19",{"date":525,"type":44},"2025-05-22",{"date":527,"type":44},"2025-02-06",{"date":529,"type":23},"2030-02-28",{"name":531,"class":84},"National Taiwan University Hospital",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":24,"phases":542,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":139},"100587462","impact-of-targeted-nutritional-apport-and-exercise-on-the-modulation-of-metabolic-and-immune-related-gene-expression-signatures-in-early-breast-cancer-ebc-patients-candidate-to-neoadjuvant-therapy-nat-100587462","NCT06928701","Impact of \"Targeted\" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)","A Phase II Randomized Trial to Evaluate the Impact of \"Targeted\" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)","NEOMET","Inclusion Criteria:\n\n* \\- Women (regardless of menopausal status) ≥ 18 years of age\n* Pathologic confirmation of breast cancer by tumor biopsy\n* Immunohistochemical assessment (as per local standards) of ER and PgR status, HER2 status;\n* Stage I-III breast cancer without evidence of distant metastases\n* Being candidate to standard neoadjuvant therapy\n* Having available tumor tissue from breast and\u002For lymph node at baseline\n* Ability to fill a nutritional daily diary\n* Medical clearance for non-agonistic physical activity\n* Written informed consent to study-specific procedures\n\nExclusion Criteria:\n\n* \\- locally advanced or inflammatory or stage IV BC;\n* tumor size \\\u003C 1 cm with negative nodes (pT1a, N0);\n* chronic diseases or orthopedic issues that might interfere with ability to undertake a dietary and physical activity program;\n* personal history of eating disorders.\n* women engaged in agonistic\u002Fvigorous sport activities, not able to be compliant to exercise schedules",{"count":541,"type":23},160,[120],"NEOMET is an exploratory randomized prospective, multicenter study whose primary aim is to explore if metabolomic signatures can be modified by a lifestyle intervention including dietary supplements and physical exercise intervention, in eBC patients candidate to NAT. Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).",[29,545],"Neoadjuvant Treatment",[547,548,549],"treatment response","metabolomics","nutritional intervention","2025-04-07",{"date":552,"type":44},"2025-04-15",{"date":554,"type":44},"2024-09-01",{"date":556,"type":23},"2026-12",{"name":558,"class":84},"University of Eastern Piedmont",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":567,"targetDuration":569,"studyType":149,"phases":4,"briefSummary":570,"conditions":571,"keywords":574,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":139},"100564033","early-changes-in-metabolic-health-in-breast-cancer-patients-initiating-endocrine-therapy-100564033","NCT06623903","Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy","Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study","EMETA","Inclusion Criteria:\n\n* Age ≥18 years\n* Invasive ER+ breast cancer\n* No diabetes treatment\n* Planned for initiation of any adjuvant endocrine therapy.\n\nExclusion Criteria:\n\n* Pregnancy or lactation,\n* Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.",{"count":568,"type":23},112,"3 Months","This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. The hypothesis is, that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months. This includes increased BMI (Body Mass Index), waist- and hip circumference, blood pressure, blood sugars, and lipids compared to when the patients initiate antihormone therapy. Concurrently, estradiol levels are expected to decrease. An estimated 112 patients initiating antihormone therapy at the Dept. of Oncology, Aarhus University Hospital (AUH) will be included in the study over 6 months from autumn 2024. Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up. The two metabolic screenings each consists of biometric measurements and a blood sample.",[29,572,573],"Metabolic Health","Estrogen Receptor Positive Breast Cancer",[575,576,577],"Early breast cancer","Metabolic health","Endocrine therapy","2024-10-01",{"date":580,"type":44},"2024-10-02",{"date":582,"type":23},"2024-11-01",{"date":584,"type":23},"2025-07-31",{"name":586,"class":84},"Aarhus University Hospital",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":24,"phases":596,"briefSummary":597,"conditions":598,"keywords":599,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":139},"100549521","phase-2-aromatherapy-in-the-treatment-of-early-breast-cancer-100549521","NCT06435104","Aromatherapy in the Treatment of Early Breast Cancer","Effects of Aromatherapy on Anxiety and Tumor Immunity of Early Breast Cancer Patients,a Pilot Study","Inclusion Criteria:\n\n1. Adult female patients (age 18-80 years) with early breast cancer confirmed by pathology.\n2. Patients have not received any anti-tumor treatment,and are planning to receive neoadjuvant chemotherapy.\n3. Patients with mild anxiety scored 50 in Self-Rating Anxiety Scale.\n4. ECOG physical status score ≤ 2 and expected survival of not less than 3 months.\n5. At least one measurable lesion should be present in the imaging examination within 2 weeks prior to enrollment.\n6. Adequate reserve of bone marrow function: white blood cell count ≥ 3.0×10\\^9\u002FL, neutrophil count ≥ 1.5 × 10\\^9\u002FL; Platelet count ≥ 70 × 10\\^9\u002FL.\n7. Basically normal liver, kidney and cardiac function:total bilirubin≤3 times the upper limit of normal value,Alanine Transaminase\u002FAspartate Aminotransferase≤2.5 times the upper limit of normal value(patients with liver metastases≤5 times the upper limit of normal value)，serum creatinine≤1.5 times the upper limit of normal value or creatinine clearance rate≥60mL\u002Fmin, left ventricular ejection fraction (LVEF) ≥ 55%,QTcF(Fridericia correction) ≤ 470 ms.\n8. Be able to understand the research process, volunteer to participate in the study, and sign informed consent.\n\nExclusion Criteria:\n\n1. Patients who are not able to receive aromatherapy:be allergic to aromatherapy materials or suffer from heterosmia.\n2. Received surgery within 2 weeks prior to enrollment.\n3. Patients with severe cardiovascular and cerebrovascular events within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except asymptomatic lacunar infarction requiring no treatment)\n4. Patients with active autoimmune diseases requiring treatment (e.g., corticosteroids or immunosuppressive drugs) within the past 2 years. Patients who need corticosteroid replacement therapy for adrenal insufficiency were excluded.\n5. Patients with a definite past medical history or present medical history of neurological or mental disorders, including epilepsy or dementia.\n6. The researchers believe that patients are not suitable to participate in any other circumstances of this study, which may interfere with the accompanying diseases or conditions of the study, or have any serious medical obstacles that may affect the safety of the subjects.","80 Years",{"count":400,"type":23},[64],"Breast cancer is a major threat to women's health, and chemotherapy is one of the most important treatment method. Chemotherapy is cytotoxic , and has a positive tumor immune effect. However, it is worth noting that anxiety caused by breast cancer itself and adverse reactions of chemotherapy not only affects the patients' quality of life, but also reduces the treatment compliance and even survival benefits of patients. Previous literatures have shown that aromatherapy may improve chemotherapy-induced anxiety and even affect anti-tumor immunity.\n\nTherefore,we envisage that aromatherapy conbimed with chemotherapy in the treatment of breast cancer in clinical practice has the advantages of improving efficacy and survival.\n\nHowever, there is still a lack of relevant clinical studies. We planned to design a prospective clinical trial to evaluate the efficacy and safety of aromatherapy combined with chemotherapy on anxiety, relevant sympathetic neurotransmitters and tumor immunity in breast cancer patients.",[29],[600,601,602,603],"Early breast Cancer","Anxiety","Aromatherapy","Neoadjuvant chemotherapy","2024-07-08",{"date":606,"type":44},"2024-07-09",{"date":608,"type":23},"2024-07",{"date":610,"type":23},"2027-01",{"name":612,"class":84},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":457,"enrollmentInfo":621,"targetDuration":4,"studyType":24,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":139},"100547189","phase-2-ql1706-plus-chemotherapy-as-neoadjuvant-therapy-in-early-high-risk-tnbc-breast-cancer-100547189","NCT06404736","QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer","A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk TNBC Early-Stage Breast Cancer (QUEEN-Dream)","QUEEN-Dream","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO\u002FCAP guidelines, histopathologically confirmed TNBC breast cancer, histological grade II, TNM stage T1cN1-cN2 or T2-T4, cN0-cN2;\n3. According to RECIST 1.1, there is at least one measurable lesion;\n4. ECOG score: 0\\~1;\n5. Tumor tissue specimens that can be used for biomarker detection;\n\nThe function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication):\n\nInclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form; Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO\u002FCAP guidelines, histopathologically confirmed ER+\u002FHER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2;\n2. According to RECIST 1.1, there is at least one measurable lesion; ECOG score: 0\\~1; Tumor tissue specimens that can be used for biomarker detection;\n\nThe function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication):\n\n(1) Absolute neutrophil count ≥1.5×109\u002FL; (2) Platelets ≥100×109\u002FL; (3) Hemoglobin ≥90 g\u002FL; (4) Serum albumin ≥30 g\u002FL; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).\n\nExclusion Criteria:\n\n1. The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism;\n2. Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);\n3. Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10 mg\u002Fday prednisone or other effective hormones), and are still using it within 2 weeks before enrollment;\n4. Severe allergic reactions to other monoclonal antibodies; Known history or evidence of interstitial lung disease or active non-infectious pneumonia;\n5. Those with known central nervous system metastasis;\n6. Suffered from other malignant tumors in the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical cancer in situ);\n7. Suffering from high blood pressure that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); the above parameters are allowed to be achieved through the use of antihypertensive treatment; there has been a hypertensive crisis or high blood pressure in the past Hypertensive encephalopathy;\n8. Have cardiac clinical symptoms or diseases that cannot be well controlled, such as (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc\\>450ms (male); QTc\\>470ms (female);\n9. Those who are receiving thrombolysis or anticoagulation therapy are allowed to use low-dose aspirin and low-molecular-weight heparin prophylactically;\n10. Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive during the baseline period, it can be re-examined. If it is still positive after the reexamination, a gastroscopy is required;\n11. The tumor invades important blood vessels, or the researcher determines based on imaging that there is a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding;\n12. Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage;\n13. Arterial\u002Fvenous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n14. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia patients, coagulation disorders, etc.);\n15. Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment;\n16. Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount \\>1.0 g;\n17. Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count \\>15×109\u002FL;\n18. Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU\u002Fml, or hepatitis C virus antibody positive; Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period;\n19. In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient's safety.",{"count":622,"type":23},73,[64],"This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel and carboplatin in a neoadjuvant setting, in high-risk, TNBC early breast cancer.",[29,626,355],"Neoadjuvant Therapy",[355,575,626],"2024-05-05",{"date":630,"type":44},"2024-05-08",{"date":632,"type":23},"2024-05-07",{"date":634,"type":23},"2030-11-07",{"name":636,"class":84},"Fudan University",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":643,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":457,"enrollmentInfo":645,"targetDuration":4,"studyType":24,"phases":647,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":4},"100547168","phase-2-ql1706-plus-chemotherapy-as-neoadjuvant-therapy-in-early-high-risk-erher2--breast-cancer-100547168","NCT06404463","QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+\u002FHER2- Breast Cancer","A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk ER+\u002FHER2- Early-Stage Breast Cancer (QUEEN-Neo)","QUEEN-Neo","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO\u002FCAP guidelines, histopathologically confirmed ER+\u002FHER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2;\n3. According to RECIST 1.1, there is at least one measurable lesion;\n4. ECOG score: 0\\~1;\n5. Tumor tissue specimens that can be used for biomarker detection;\n6. The function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication):\n\n(1) Absolute neutrophil count ≥1.5×109\u002FL; (2) Platelets ≥100×109\u002FL; (3) Hemoglobin ≥90 g\u002FL; (4) Serum albumin ≥30 g\u002FL; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).\n\nExclusion Criteria:\n\n1. The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);\n2. Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10 mg\u002Fday prednisone or other effective hormones), and are still using it within 2 weeks before enrollment;\n3. Severe allergic reactions to other monoclonal antibodies;\n4. Known history or evidence of interstitial lung disease or active non-infectious pneumonia;\n5. Those with known central nervous system metastasis;\n6. Suffered from other malignant tumors in the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical cancer in situ);\n7. Suffering from high blood pressure that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); the above parameters are allowed to be achieved through the use of antihypertensive treatment; there has been a hypertensive crisis or high blood pressure in the past Hypertensive encephalopathy;\n8. Have cardiac clinical symptoms or diseases that cannot be well controlled, such as (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc\\>450ms (male); QTc\\>470ms (female);\n9. Those who are receiving thrombolysis or anticoagulation therapy are allowed to use low-dose aspirin and low-molecular-weight heparin prophylactically;\n10. Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive during the baseline period, it can be re-examined. If it is still positive after the reexamination, a gastroscopy is required;\n11. The tumor invades important blood vessels, or the researcher determines based on imaging that there is a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding;\n12. Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage;\n13. Arterial\u002Fvenous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n14. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia patients, coagulation disorders, etc.);\n15. Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment;\n16. Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount \\>1.0 g;\n17. Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count \\>15×109\u002FL;\n18. Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU\u002Fml, or hepatitis C virus antibody positive;\n19. Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period;\n20. In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient's safety.",{"count":646,"type":23},76,[64],"This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC\u002FEC in a neoadjuvant setting, in high-risk, ER+\u002FHER2- early breast cancer.",[29,626,650],"HR+HER2- Breast Cancer",{"date":630,"type":44},{"date":653,"type":23},"2024-05-06",{"date":655,"type":23},"2030-11-06",{"name":636,"class":84},{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":665,"targetDuration":4,"studyType":24,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":675,"leadSponsor":676,"locationsCount":678},"100544662","phase-2-trial-for-treatment-of-high-risk-bc-with-two-sequences-of-neoadjuvant-chemotherapy-with-pembrolizumab-100544662","NCT06371807","Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab","Immunogenicity Profile of Neoadjuvant Keytruda in Combination With Anthracycline Versus Carboplatin\u002FPAclitaxel Containing Chemotherapy Regimen for The Treatment of Early-stage, TILs-Positive, Triple-Negative Breast CanceR","KEYPARTNER","Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply:\n\n1. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.\n2. Be a female or male participant who is at least 18 years of age on the day of signing informed consent.\n3. Have locally histologically confirmed diagnosis of invasive carcinoma of the breast that is classified as TNBC, as defined by the most recent ASCO\u002FCAP guidelines.\n4. Has locally confirmed tumor infiltrating lymphocytes (stromal) (sTILs) equal to or above 10%, as defined by the most recent International Guidelines on TIL Assessment in Breast Cancer.\n5. Have previously untreated non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current AJCC staging criteria for breast cancer staging criteria as assessed by the investigator based on radiological and\u002For clinical assessment:\n\n   1. T1c, N1-N2\n   2. T2, N0-N2\n   3. T3, N0-N2\n   4. T4a-d, N0-N2 Note: bilateral tumors (ie, synchronous cancers in both breasts) and\u002For multi-focal (ie, 2, separate lesions in the same quadrant)\u002Fmulti-centric (ie, 2 separate lesions in different quadrants) tumors are allowed, as well as inflammatory breast cancer, and the tumor with the most advanced T stage should be used to assess the eligibility. If the subject has either bilateral or multi-focal\u002Fmulti-centric disease, TNBC needs to be confirmed in at least 2 lesions\u002Fbreast\u002Ffocus. Beyond this rule, the extent of tumor biopsy confirmation is based on the best clinical judgment by local investigators.\n6. Provide a core needle biopsy consisting of at least 3 separate tumor cores from the primary tumor at screening to the designated central biobank (or responsible laboratories) and is willing to provide a second biopsy at the end of the first cycle of treatment.\n\n   Note: Detailed instructions on sample collection, processing, storage and shipment to the central biobank are provided in the Laboratory Manual.\n7. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.\n8. Have left ventricular ejection fraction (LVEF) of ≥50% or ≥ institution lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.\n9. Have adequate organ function as defined in the following table (Table 2). Specimens must be collected within 28 days prior to the start of study intervention.\n10. Male participants:\n\nA male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 12 months after the last dose of cyclophosphamide or 6 months after last chemotherapy (whichever occurs last) and refrain from donating sperm during this period.\n\nFemale participants:\n\nA female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\na. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 12 months after the last dose of cyclophosphamide or 6 months after last chemotherapy (whichever occurs last).\n\n\\-\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n2. Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.\n3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n4. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.\n\n   Note: subject should be excluded if he\u002Fshe received an investigational agent with anticancer or anti-proliferative intent within the last 12 months.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n8. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n9. Has significant cardiovascular disease, such as:\n\n   1. History of myocardial infarction, acute coronary syndrome or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the last 6 months\n   2. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV\n10. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n11. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n12. Has a known history of active TB (Bacillus Tuberculosis).\n13. Has an active infection requiring systemic therapy.\n14. If surgery was performed prior to screening, has persistent adverse events or incomplete wound healing considered clinically relevant by the treating investigator.\n15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n17. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 12 months after the last dose of cyclophosphamide or 6 months after last chemotherapy (whichever occurs last).\n18. Has had an allogenic tissue\u002Fsolid organ transplant.\n19. Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial and to consent",{"count":666,"type":23},20,[64],"Phase II, randomized, Active-controlled open label trial for treatment of high risk, HR-\u002FHER2- (triple negative) breast cancer, with two sequences of neoadjuvant chemotherapy on a background of pembrolizumab",[29,670],"Triple Negative Breast Cancer","2024-04-15",{"date":673,"type":44},"2024-04-17",{"date":608,"type":23},{"date":556,"type":23},{"name":677,"class":84},"Fundacao Champalimaud",3,{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":684,"acronym":4,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":398,"enrollmentInfo":686,"targetDuration":4,"studyType":24,"phases":688,"briefSummary":689,"conditions":690,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":139},"100542363","phase-2-efficacy-and-safety-of-dalpiciclib-with-endocrine-therapy-as-adjuvant-treatment-in-hr-her2--early-breast-cancer-100542363","NCT06341894","Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+\u002F HER2- Early Breast Cancer","Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer","Inclusion Criteria:\n\n* Patient is ≥ 18 years-old\n* Patient is female with known menopausal status (postmenopausal or premenopausal\u002Fperimenopause)\n* Patient with histologically confirmed HR+\u002FHER2- early breast cancer (immunohistochemical ER and\u002For PR≥10%)\n* Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0\n* Patients with or without neoadjuvant or adjuvant chemotherapy\u002F radiotherapy were eligible for inclusion\n* From operation to enrollment should not exceed 12 months\n* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* metastatic disease (Stage IV) or inflammatory breast cancer\n* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.\n* Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180\u002F110);\n* A history of allergy to the drugs in this study；\n* Unable or unwilling to swallow tablets\n* History of gastrointestinal disease with diarrhea as the major symptom.",{"count":687,"type":23},1163,[64],"The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium \u002Fhigh risk hormone receptor-positive, HER2-negative Early Breast Cancer.",[29],"2024-03-25",{"date":693,"type":44},"2024-04-02",{"date":695,"type":44},"2023-11-17",{"date":697,"type":23},"2029-06",{"name":699,"class":84},"The First Affiliated Hospital with Nanjing Medical University"]