[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-neoplasm-female\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-neoplasm-female":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,43,66,108,137,175,204,228,249,271,299,320,349,370,394,422],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100471333","phase-3-a-randomized-trial-of-five-fraction-partial-breast-irradiation-rapid2-100471333",false,"NCT05417516","A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)","A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)","Inclusion Criteria:\n\nFor inclusion in this study, patients must fulfill all of the following criteria:\n\n1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).\n2. Treated by BCS with microscopically clear resection margins \\>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.\n3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and\u002For biopsy, for women with unifocal tumours \\\u003C= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy\n\nExclusion Criteria:\n\nPatients who satisfy any of the following exclusion criteria are NOT eligible for this study:\n\n1. Age less than 50 years.\n2. Known to be BRCA 1 and\u002For BRCA 2 positive.\n3. Tumour size \\>3cm in greatest diameter on pathological examination.\n4. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \\\u003C= 3cm remain eligible\n5. Evidence of a DCIS component \\> 3cm\n6. Lobular carcinoma only.\n7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).\n8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).\n9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.\n10. Known pregnancy or currently lactating.\n11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).\n12. Inability to plan the patient for the experimental technique.","FEMALE","50 Years","120 Years",{"count":20,"type":21},910,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.",[27,28,29],"Breast Neoplasm Female","Radiotherapy","Cosmetic Outcome","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":34},"2023-11-20",{"date":38,"type":21},"2031-11",{"name":40,"class":41},"Ontario Clinical Oncology Group (OCOG)","OTHER",29,{"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100293174","phase-4-neoadjuvant-weekly-paclitaxel-and-biomarkers-of-therapy-response-100293174",true,"NCT03096418","Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response","Inclusion Criteria:\n\n* Women with pathologically demonstrated breast cancer\n* Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel.\n* Patients must not have metastatic disease on staging work-up per institutional guidelines.\n* A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor (preferred) or lymph node. A minimum of 8 slides must be available.\n* The primary tumor or lymph node must be readily biopsied by surgery or radiology teams.\n* The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may include ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.All imaging will be performed per standard of care at the discretion of the treating physicians.\n* Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer. However, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not FDA approved for the treatment of the patient's current breast cancer, are permitted.\n* Patients must have adequate organ and marrow function as determined by the treating oncologist.\n* Patient must be willing to undergo additional biopsy of breast tumor or lymph node.\n* Patient must have the ability and willingness to sign a written informed consent document.\n* Women of childbearing potential (per institutional policy) must agree to use effective contraception as discussed with treating oncologist for the duration of the study.\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil).\n* Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications.\n* Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements as determined by treatment physician.\n* Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial.","18 Years",{"count":52,"type":21},50,[54],"PHASE4","The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.",[27],"2026-06-15",{"date":31,"type":34},{"date":60,"type":34},"2017-03-13",{"date":62,"type":21},"2027-06",{"name":64,"class":41},"University of Wisconsin, Madison",2,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100636798","targeting-stress-driven-inflammatory-and-angiogenic-pathways-with-brief-act-to-enhance-neoadjuvant-chemotherapy-response-in-locally-advanced-breast-cancer-100636798","NCT07570368","Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer","Effect of Brief Acceptance and Commitment Therapy on Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer Through Modulation of Inflammatory and Angiogenic Biomarkers.","Inclusion Criteria:\n\n* Female patients aged 40-65 years\n* Histologically confirmed locally advanced breast cancer\n* Planned to undergo neoadjuvant chemotherapy\n* ECOG performance status 0-2\n* Able to provide informed consent\n* Willing to participate in psychological intervention sessions\n\nExclusion Criteria:\n\n* Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥27\n* Active infection or inflammatory disease\n* Known autoimmune disease\n* Cognitive impairment or psychiatric condition interfering with participation\n* Concurrent participation in another interventional study","40 Years","65 Years",{"count":76,"type":21},54,[78],"NA","This clinical trial aims to learn whether a brief psychological therapy called Brief Acceptance and Commitment Therapy (Brief-ACT) can improve the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer. It will also examine how this therapy affects stress levels and certain blood markers related to inflammation and tumor growth.\n\nThe main questions this study aims to answer are:\n\nDoes Brief-ACT improve the rate of pathological complete response (pCR) after chemotherapy? Does Brief-ACT reduce levels of inflammatory and angiogenic biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF)? Does Brief-ACT reduce psychological stress in patients undergoing chemotherapy?\n\nResearchers will compare patients who receive Brief-ACT in addition to standard chemotherapy with those who receive standard chemotherapy alone to see if there are differences in treatment response, stress levels, and biomarker levels.\n\nParticipants will:\n\nReceive neoadjuvant chemotherapy according to standard treatment protocols Be assigned to receive Brief-ACT sessions or no additional psychological intervention Attend regular clinic visits for treatment and monitoring Provide blood samples at specific time points for laboratory analysis Complete questionnaires to assess psychological stress",[81,27,82,83],"Breast Cancer","Locally Advanced Breast Cancer (LABC)","Locally Advanced Breast Cancer",[85,86,87,88,89,90,91,92,93,94,95,96,97],"breast cancer","Locally advanced breast cancer","brief acceptance and commitment therapy","acceptance and commitment therapy","neoadjuvant chemotherapy","clinical chemotherapy response","inflammatory biomarkers","angiogenic biomarkers","interleukin-6","neutrophil to lymphocyte ratio","vascular endothelial growth factor","psychological stress","psycho-oncology","NOT_YET_RECRUITING","2026-04-29",{"date":101,"type":34},"2026-05-06",{"date":103,"type":21},"2026-04-28",{"date":105,"type":21},"2027-01",{"name":107,"class":41},"Universitas Airlangga",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":65},"100622732","feasibility-and-acceptibility-of-a-multi-site-trial-of-time-restircted-eating-during-chemotheraply-for-breast-cancer-100622732","NCT07387445","Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.","Time Restricted Eating During Chemotherapy for Breast Cancer","Inclusion Criteria:\n\n* Age 25-99 at time of consent\n* English language or Spanish language (based on availability of lab interpreters)\n* ECOG 0 or 1\n* Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval.\n* Demonstrates adequate organ function (absolute neutrophil count ≥ 1,500\u002FμL).\n* All screening labs to be obtained within 30 days prior to registration.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.\n* Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Women with type 1 or insulin dependent type 2 diabetes\n* Women with BMI \\> 45kg\u002Fm2 and \\\u003C 18.5 kg\u002Fm2\n* Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* Shift workers\n* Women with a history of eating disorders\n* Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \\>4kg)\n* Uncontrolled HIV\u002FAIDS or active viral hepatitis\n* Any prior malignancy \\\u003C5 years, chemotherapy within the last year or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Breast cancer recurrence classified by the treating medical oncologist\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity, as determined by study PI\n* Illicit drug use within previous 3 months or excessive use of alcohol (i.e., \\> 2 drinks\u002Fday)\n* Currently participating in Weight Watcher's or another weight loss program, including weight loss medication such as GLP-1 medications.\n* Myocardial infarction\n* Congestive heart failure\n* Chronic hepatitis\n* Cirrhosis\n* Chronic pancreatitis\n* History of solid organ transplantation","25 Years","99 Years",{"count":118,"type":21},40,[78],"This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.",[122,27,81],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[85,124,125,126,127],"fasting","intermittent fasting","time restricted eating","chemotherapy initiation","2026-04-27",{"date":130,"type":34},"2026-05-01",{"date":132,"type":34},"2026-02-01",{"date":134,"type":21},"2026-12-31",{"name":136,"class":41},"University of Illinois at Chicago",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100633498","hismar-intraoperative-margin-assessment-using-the-histolog-scanner-to-reduce-reoperation-in-breast-conserving-surgery-100633498","NCT07527468","HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery","HISMAR: A Prospective Post-Market Performance Follow-up Study of the Histolog Scanner for Intraoperative Margin Assessment in Breast-Conserving Surgery for High-Risk Histological Subtypes (ILC, DCIS, NST+DCIS)","HISMAR","1. Female patient, aged 18 years or older at time of surgery.\n2. Pre-operative core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) with histological diagnosis of one of the following:\n\n   1. invasive lobular carcinoma (ILC\u002FCLI),\n   2. pure ductal carcinoma in situ (DCIS), or\n   3. invasive carcinoma of non-special type (NST) with an associated DCIS component.\n3. Planned breast-conserving surgery (BCS \u002F lumpectomy) at CHVR.\n4. Signed electronic informed consent (eIC) obtained prior to any study procedure.\n\nExclusion Criteria:\n\n1. Pregnancy (confirmed or suspected) at time of surgery.\n2. Prior neo-adjuvant treatment (hormonal therapy or chemotherapy) for the current breast cancer diagnosis.\n3. Surgical indication for mastectomy rather than BCS.\n4. Known hypersensitivity or allergy to acriflavine (fluorescent staining agent used with the Histolog Scanner).\n5. Incapacity to provide informed consent.\n6. Previous enrolment in this study.",{"count":146,"type":21},228,[78],"This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS).\n\nAfter lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing.\n\nBased on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.",[81,150,151,27],"Ductal Carcinoma In Situ","Invasive Lobular Carcinoma",[153,154,155,156,157,158,159,160,161,162,163,164],"breast-conserving surgery","lumpectomy","surgical margins","intraoperative imaging","confocal microscopy","reoperation","re-excision","histological scanning","DCIS","ILC","post-market performance follow-up","PMPF","2026-04-07",{"date":167,"type":34},"2026-04-14",{"date":169,"type":21},"2026-09-01",{"date":171,"type":21},"2030-06-01",{"name":173,"class":41},"Hôpital du Valais",1,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":190,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":174},"100628736","a-novel-approach-in-the-evaluation-of-breast-masses-with-doppler-us-100628736","NCT07465523","A Novel Approach in the Evaluation of Breast Masses With Doppler US","A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation","Inclusion Criteria:\n\n* Those with solid breast masses\n* Female patients\n* Those with pathology results\n\nExclusion Criteria:\n\n* Hypovascular masses\n* Cystic breast masses\n* Cases with mastitis",{"count":183,"type":21},90,"OBSERVATIONAL","In cases with breast masses, Doppler resistive index values will be calculated for the mass and surrounding healthy tissue and the opposite healthy breast tissue, and their effect on distinguishing between benign and malignant masses will be evaluated.",[27,187,188,189],"Benign Breast Neoplasm","Malign Breast Neoplasm","Doppler Ultrasound Diagnosis",[191,192,193,194],"Breast Mass","Doppler Ultrasound","B-Mode Ultrasound","Resistive Index","2026-03-12",{"date":197,"type":34},"2026-03-16",{"date":199,"type":34},"2026-03-04",{"date":201,"type":21},"2026-05-19",{"name":203,"class":41},"Ahmet Yesildag",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":174},"100584663","the-fyi-on-mri-a-multilevel-decision-support-intervention-for-screening-breast-mri-100584663","NCT06892275","The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI","Inclusion Criteria:\n\n* female\n* aged 18-74 years\n* self-identifying as Black and\u002For Latina\n* no personal history of breast cancer\n* English- or Spanish-speaking\n* having received a mammogram with normal results in the last 12 months\n* ≥20% lifetime breast cancer risk per the NCI Breast Cancer Risk Assessment Tool (BCRAT)\n\nExclusion Criteria:\n\n* aged \\\u003C18 or ≥75\n* pregnancy","74 Years",{"count":212,"type":21},80,[78],"The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1.",[27,216,217,218],"Early Detection of Cancer","Hereditary Breast and Ovarian Cancer Syndrome","Magnetic Resonance Imaging","2025-09-26",{"date":221,"type":34},"2025-09-30",{"date":223,"type":34},"2025-06-01",{"date":225,"type":21},"2027-12",{"name":227,"class":41},"Georgetown University",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":4},"100606813","piloting-18f-fapi-petmri-for-applications-in-breast-cancer-100606813","NCT07180433","Piloting 18F-FAPI PET\u002FMRI for Applications in Breast Cancer","Inclusion Criteria:\n\n* Inclusion criteria are accepting to undergo 18F-FAPI PET\u002FMRI examinations and\n\n  1. diagnosed with local invasive breast cancer,\n  2. scheduled for neoadjuvant therapy as primary treatment,\n  3. has recurrent or new breast cancer, or\n  4. scheduled for neoadjuvant therapy as primary treatment with FDG-PET\u002FCT applied for staging.\n\nExclusion Criteria:\n\n* other primary malignancies than breast cancer, renal insufficiency or know allergy towards contrast agents, and MR incompatible implants.","80 Years",{"count":236,"type":21},60,[78],"Breast cancer is the most common type of cancer in Norwegian women, with 4,224 new cases in 2022. More precise diagnosis are expected to result in more accurate assessment of treatment effect, and to contribute to both providing better treatment and reducing overtreatment. Fibroblast activating protein (FAP) is expressed in the tumor stroma of 90% of all epithelial-based tumors, including breast tumors. Inhibitors for this protein (FAPI) has been developed for use as radioactive tracers. Breast tumors of various histopathological types, and local metastatic lymph nodes, have shown high uptake for such tracers. The main aim of this project is to establish 18F-FAPI PET\u002FMRI for use in breast cancer in a wide range of disease stages. We will evaluate how FAPI PET\u002FMRI correlates with histopathological assessment, the method's ability to grade tumors - including assessment of treatment - compared to CT, scintigraphy and FDG PET\u002FCT, and ability to detect local recurrence.",[27],"2025-09-11",{"date":242,"type":34},"2025-09-18",{"date":244,"type":21},"2025-10-01",{"date":246,"type":21},"2038-12-31",{"name":248,"class":41},"St. Olavs Hospital",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":269,"locationsCount":174},"100444720","sbrt-in-early-breast-cancer-in-elderly-women-100444720","NCT05071105","SBRT in Early Breast Cancer in Elderly Women","Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone","Inclusion Criteria:\n\n* Age ≥ 75 years\n* Histologically confirmed diagnosis of local disease only (cT1-T2 N0 M0)\n* Luminal like A or B (estrogen receptor positive and\u002For progesterone receptor positive and Her2 negative Tumors)\n* SBRT within 2 months after hormonal therapy start\n\nExclusion Criteria:\n\n* Metastatic Disease\n* Evidence of loco-regional nodal disease\n* Multifocal or multicentric tumors\n* Prior radiotherapy to the region of the study cancer that would result in overlap of therapy fields\n* Concurrent systemic disorders that contraindicate radiotherapy","75 Years",{"count":258,"type":21},30,[78],"Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy.\n\nIn Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor.\n\nIn recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery.\n\nStereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting.\n\nAgainst this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.",[27],[28],"2025-05-25",{"date":265,"type":34},"2025-05-30",{"date":267,"type":34},"2021-01-01",{"date":134,"type":21},{"name":270,"class":41},"University of Rome Tor Vergata",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":285,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100341848","delayed-immediate-versus-delayed-breast-reconstruction-in-breast-cancer-patients-with-mastectomy-and-radiation-therapy-100341848","NCT03730922","Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy","The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial","Inclusion Criteria:\n\n* Woman \\>18 years who are offered a mastectomy for invasive breast can-cer pT1-3, pN0-N3, M0 and wish reconstruction. The patient can be inclu-ded no matter the status of estrogen receptor, progesterone receptor, malignancy grade, and HER2 status.\n* The patient is a candidate for loco-regional radiation therapy according to national or institutional guidelines.\n* Highly selected patients with inflammatory breast cancer, namely those with complete or near complete response to neoadjuvant systemic thera-py judged by imaging and clinical examination before surgery. Any skin edema and clinical signs of skin involvement must have disappeared during systemic therapy. It is highly recommended that the decision to offer an inflammatory breast cancer patient inclusion in the DBCG RT Recon trial is made during a multidisciplinary team conference.\n* Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either as new standard or as part of a trial during the course of the trial is accepted.\n* Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted.\n* Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist esti-mates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinoma of the skin.\n* Life expectancy minimum 10 years.\n\nExclusion Criteria:\n\n* Pregnant or lactating.\n* Previous breast cancer or Ductal carcinoma in Situ (DCIS).\n* Bilateral breast cancer.\n* Previous radiation therapy to the chest region.\n* Previous non-breast malignancy (not including carcinoma in situ of the cervix or colon, melanoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin) within 5 years.\n* Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up.\n* Not being able to participate due to language or other personal issues.\n* Life expectancy less than 10 years.",{"count":279,"type":21},590,[78],"In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.",[27,283,284],"Complication of Radiation Therapy","Breast Implant; Complications",[286,287,288],"Breast cancer","Reconstruction","Post mastectomy radiotherapy","2025-02-04",{"date":291,"type":34},"2025-02-06",{"date":293,"type":34},"2020-01-01",{"date":295,"type":21},"2035-11",{"name":297,"class":41},"Danish Breast Cancer Cooperative Group",8,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":174},"100441358","efficacy-of-preparation-in-self-hypnosis-by-anchoring-versus-conversational-hypnosis-used-alone-or-combined-in-patients-undergoing-breast-macrobiopsies-100441358","NCT05027321","Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies","Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies: a Randomized Study","Inclusion Criteria:\n\n* aged 18 or over,\n* referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy,\n* naive of any hypnosis,\n* having given free, informed and written consent,\n* being affiliated to a social security scheme or beneficiary of such scheme\n\nExclusion Criteria:\n\n* having a major hearing loss,\n* suffering from identified mental or psychotic disorders,\n* not understanding the French language,\n* having already had hypnosis practices,\n* having an ongoing pregnancy,\n* being the subject of a safeguard measure",{"count":307,"type":21},100,[78],"The incidence of breast cancer and its mortality are reduced thanks in particular to early detection.\n\nOften performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act.\n\nFaced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination.\n\nInvestigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management.\n\nHowever, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.",[27],"2024-09-12",{"date":313,"type":34},"2024-09-19",{"date":315,"type":34},"2022-10-11",{"date":317,"type":21},"2025-01",{"name":319,"class":41},"Hospital St. Joseph, Marseille, France",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":348},"100460615","wearable-enhanced-fitness-tracking-for-metastatic-breast-cancer-patients-using-endocrine-treatment-and-palbociclib-100460615","NCT05277935","Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib","WEFITTER","Inclusion Criteria:\n\n* Female patients ≥ 18 years of age diagnosed with hormone receptor-positive\u002F human epidermal growth factor receptor 2- negative metastatic breast cancer undergoing treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane or anastrozole) or fulvestrant as first-line therapy, or in treatment with Palbociclib and fulvestrant as second-line or posterior-line therapy in the metastatic setting; may be using ovarian suppression if the patient is premenopausal.\n* The patient must be on treatment for at least three (3) months with Palbociclib and endocrine therapy.\n* Evidence of a signed and dated informed consent document, physically or digitally, indicating that the research participant was informed about all relevant aspects of the study;\n* The patient agrees not to participate in another study with drug intervention while on treatment.\n* Have performance status according to the Eastern Cooperative Oncology Group\n* Have access to a compatible smartphone and 3G or 4G internet connection\n\nExclusion Criteria:\n\n* Patients considered to be at poor medical risk due to uncontrolled serious medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples: uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent; between others.\n* Patients who have a life expectancy of \\\u003C 3 months.\n* Treatment with any product under investigation during the last 28 days;\n* Another acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that Page 10 de 21 Version 6.0 could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for inclusion in the study. study.\n* Illiterate patients or those with a low level of education that may prevent the correct use of the Wecancer application and\u002For the watch with monitoring of physical activity.",{"count":328,"type":21},68,[78],"Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.",[27,332],"Quality of Life",[334,335,336,337,338],"Quality of life","Metastatic breast cancer","Metastasis","Exercise","Palbociclib","2024-08-23",{"date":341,"type":34},"2024-08-26",{"date":343,"type":34},"2022-04-22",{"date":345,"type":21},"2025-03-01",{"name":347,"class":41},"Beneficência Portuguesa de São Paulo",4,{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":256,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":174},"100534077","a-prospective-open-multicenter-single-arm-clinical-studie-of-docetaxel-carboplatin-combined-with-inetetamab-and-pyrotinib-in-the-treatment-of-local-advanced-her2-positive-breast-cancer-100534077","NCT06234137","A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer","neoPICD","Inclusion Criteria:\n\n1. Female patients aged 18-75 years old;\n2. ECOG score 0-1;\n3. Breast cancer meets the following criteria: Histologically confirmed invasive breast cancer, primary tumor diameter \\> 2 cm as determined by standard evaluation methods at the research center; tumor stage: locally advanced;\n4. HER2 expression-positive breast cancer confirmed by pathological examination;\n5. Known hormone receptor status (ER and PR);\n6. The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of white blood cell and platelet-raising drugs):\n\n(1) Blood routine: neutrophil (ANC) \\>= 1.5×10\\^9\u002FL; platelet count (PLT) \\>= 90×10\\^9\u002FL; hemoglobin (Hb) \\>= 90 g\u002FL; (2) Blood biochemistry: total bilirubin (TBIL) \\\u003C= upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 1.5×ULN; alkaline phosphatase \\\u003C= 2.5×ULN; urea nitrogen (BUN) and creatinine (Cr) \\\u003C= 1.5×ULN; (3) Echocardiography: left ventricular ejection fraction (LVEF) \\>= 60%; (4) 12-lead ECG: Fridericia-corrected QT interval (QTcF) \\\u003C 470 msec; 7. Female patients who are not menopausal or surgically sterilized: agree to abstain from sex or use effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; 8. Voluntarily join the study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. IV (metastatic) breast cancer;\n2. Received anti-tumor therapy or radiotherapy for any malignant tumor in the past, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;\n3. Receiving anti-tumor therapy in other clinical trials at the same time, including endocrine therapy, bisphosphonate therapy or immunotherapy;\n4. Received major surgical operations unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical operations;\n5. Severe cardiac disease or discomfort, including but not limited to the following: a history of heart failure or systolic dysfunction (LVEF \\\u003C 60%); high-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \\> 100 bpm , significant ventricular arrhythmia (eg, ventricular tachycardia) or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV block); antianginal medication indicated angina pectoris; clinically significant heart valve disease; transmural myocardial infarction on ECG; poorly controlled hypertension (systolic \\> 180 mmHg and\u002For diastolic \\> 100 mmHg);\n6. Inability to swallow, intestinal obstruction, or other factors that affect drug taking and absorption;\n7. Those who are known to have a history of allergy to the drug components of this regimen; have a history of immunodeficiency, including HIV positive test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;\n8. Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug;\n9. Have serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition that the investigator considers the patient unsuitable to participate in this study.",{"count":357,"type":21},154,[78],"This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0\u002Fis, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.",[27],"2024-01-23",{"date":363,"type":34},"2024-01-31",{"date":365,"type":34},"2021-11-27",{"date":367,"type":21},"2031-08-01",{"name":369,"class":41},"Wang Ouchen",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":392,"locationsCount":4},"100530970","intelligent-remote-intervention-for-high-risk-breast-cancer-populations-100530970","NCT06193707","Intelligent Remote Intervention for High-risk Breast Cancer Populations","Assessment of the Effect of Intelligence Remote Intervention on High-Risk Populations for Breast Cancer","Inclusion Criteria:\n\n* Female; Age\\>=18; Having breast BI-RADS 3 nodules or higher; Informed consent signed.\n\nExclusion Criteria:\n\n* Having any other known breast diseases; Having any major malignant diseases; Having no access to the remote devices or don't know how to use them.","60 Years",{"count":379,"type":21},1250,[78],"The goal of this clinical trial is to compare the effects of modern remote health intervention regime with traditional in-person intervention strategies for high-risk breast cancer groups that with BI-RADS 3 or higher nodules.\n\nThe main questions it aims to answer are:\n\n* Can the remote health intervention be more effective in slowing down the progression of breast nodules than the traditional in-person intervention?\n* Can the remote health intervention be more effective in minimizing the deterioration of the disease and reducing the risk of death in patients than the traditional in-person intervention?\n* Can the knowledge, belief and behavioral change of breast nodule population improve after receiving remote health intervention compared with traditional health management model?\n\nParticipants will be divided into 2 groups, the Experimental group and the Control group. Participants in the Experimental group will be offered with modern remote interventions for 2 years, as describe below:\n\n* Teleconsultations: This involves using video calls, or phone calls once a month to connect patients for consultations, follow-ups, and discussions about conditions and symptom management.\n* Remote Monitoring and Wearable Devices: Wearable devices and remote monitoring tools like Infrared Breast Temperature Detector and Dynamic blood pressure detector will be used once a week to track patients' vital signs and symptoms remotely.\n* Mobile Applications: Specialized mobile apps will be used to provide a platform for patients to access educational materials, track their progress, manage management schedules, record symptoms, and connect with support groups or online communities.\n* Educational Platforms and Remote Health Education: Online platforms and resources provide educational materials about breast cancer, treatment options, potential side effects, lifestyle adjustments, and overall wellness. These resources empower patients by providing comprehensive information.\n\nParticipants in the Control group will be offered with traditional strategies provided in the 'Breast Cancer Screening Guideline for Chinese Women': Ultrasound follow-up review is recommended no less than 3 to 6 months later. If there is no change at 2-year follow-up, it can be downgraded to BI-RADS 2; if there is suspicious change in the lesion during follow-up, biopsy should be considered to clarify the nature of the pathology.",[383,27,384,385],"Ultrasonography","Breast Carcinoma","Health Education","2023-12-20",{"date":388,"type":34},"2024-01-05",{"date":390,"type":21},"2024-01",{"date":225,"type":21},{"name":393,"class":41},"Qianfoshan Hospital",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100474001","phase-4-comprehensive-analysis-of-spatial-temporal-and-molecular-patterns-of-ribociclib-efficacy-and-resistance-in-advanced-breast-cancer-patients-100474001","NCT05452213","Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients","CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients","CAPTOR-BC","Inclusion Criteria:\n\n1. Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with cycline dependent kinase 4\u002F6 (CDK4\u002F6) inhibitors is allowed in the adjuvant setting)\n2. Written informed consent prior to beginning of trial specific procedures\n3. Subject must be female and aged ≥ 18 years on the day of signing informed consent\n4. Locally advanced or metastatic breast cancer not amenable to curative treatment\n5. Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory\n6. Histologically confirmed estrogen receptor (ER) positive and\u002F or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard.\n7. corrected QT (QTcF) interval \\\u003C 450 ms\n8. Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory\n9. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the trial through 21 days after the last dose of trial treatment.\n10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Concurrent participation in a study with an investigational agent\u002Fdevice or within 14 days of study entry or 5 half-lives of the respective investigational agent\u002Fdevice, whichever is longer\n2. Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.\n3. Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion\n4. Patients who are pregnant or lactating.\n5. Patients with existing or patients who are at significant risk of developing corrected QT interval (QTc) prolongation. This includes\n\n   * patients with long QT syndrome\n   * uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmia\n   * electrolyte abnormalities\n6. Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib.\n7. Patients with active systemic infections (for example, bacterial infection requiring intravenous antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection requiring systemic therapy) or viral load (such as known human immunodeficiency virus positivity or with known active hepatitis B or C, for example, hepatitis B surface antigen positive).\n8. Patients with serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea).\n9. Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)",{"count":403,"type":21},1000,[54],"This is a single-arm, open-label phase IV study of patients with advanced HR+\u002FHER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.",[81,407,27,408,409,410,411],"Breast Neoplasms","Breast Cancer Female","HER2-negative Breast Cancer","Hormone Receptor-positive Breast Cancer","Advanced Breast Cancer","2023-04-14",{"date":414,"type":34},"2023-04-18",{"date":416,"type":34},"2022-10-12",{"date":418,"type":21},"2026-10",{"name":420,"class":41},"Institut fuer Frauengesundheit",52,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":174},"100445059","phase-2-the-efficacy-and-safety-of-anlotinib-combined-with-fulvestrant-in-patients-with-advanced-breast-cancer-100445059","NCT05075512","The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer","A Prospective Study on Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With HR-positive and HER2-negative, Secondary Endocrine-resistant, Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Aged 18 years or older female；\n* ECOG score 0-1;\n* Life expectancy is not less than 12 weeks;\n* Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer;\n* Premenopausal women have taken effective ovarian function suppression methods, such as drug suppression or ovariectomy;\n* At least one objectively measurable breast cancer lesions according to RECIST 1.1 ;\n* No more than one systemic chemotherapy for metastatic disease;\n* Disease relapse within 12 months after at least 24 months endocrine adjuvant therapy, or disease progress after at least 6 months endocrine salvage therapy;\n* Normal function of main organs and bone marrow: Hemoglobin≥90g\u002FL; Neutrophil count (ANC)≥1.5×109\u002FL; Platelet count (PLT)≥80×109\u002FL; Total bilirubin≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤5×ULN if has liver metastasis); Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60mL\u002Fmin (Cockcroft-Gault formula);\n* Sign the informed consent;\n\nExclusion Criteria:\n\n* Have received prior fulvestrant or anti-angiogenic drug treatment, or known to be allergic to any excipients in the study;\n* Visceral crisis;\n* Uncontrolled or high-burden CNS metastases;\n* Unable to swallow;\n* Abnormal coagulation function;\n* Tumor has invaded important blood vessels and may cause fatal bleeding;\n* Pleural effusion or pericardial effusion that requiring repeated drainage;\n* Hypertension that cannot be well controlled by a single antihypertensive drug;\n* Unstable angina, myocardial infarction within 6 months, serious arrhythmias;\n* The history of immunodeficiency, including HIV or other obtained or congenital immunodeficiency diseases, or a history of organ transplantation;\n* Poorly controlled diabetes;\n* Abnormal urine protein, and the 24-hour quantification suggests urine protein ≥1.0g;\n* Bleeding constitution or medical history\n* Unhealed wounds, ulcers or fractures;\n* Have arterial\u002Fvenous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;\n* In other clinical trials of anti-tumor drugs simultaneously;\n* Other concomitant disease or disability that endangers safety according to the judgment of investigator;",{"count":118,"type":21},[431],"PHASE2","The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.",[27],"2021-10-10",{"date":436,"type":34},"2021-10-12",{"date":438,"type":34},"2021-09-01",{"date":440,"type":21},"2026-08-31",{"name":442,"class":41},"Zhejiang Cancer Hospital"]