[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-stage-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-stage-i":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,49,73,105,136,162,197,249,274,303,330,355,379,403,424,447,471,494,526,544,570],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100577736","effect-of-meal-timing-during-cancer-treatment-in-patients-in-alaska-a-randomized-clinical-trial-100577736",false,"NCT06802172","Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Male or female\n* Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC\n* Age≥21 years\n* Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)\n* Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)\n* Histologically or cytologically confirmed solid tumor (adjuvant)\n* BMI≥18.5 kg\u002Fm2\n* Plan to receive neoadjuvant or adjuvant therapy\n* Planned duration of neoadjuvant or systemic adjuvant therapy for \\>3 months to allow sufficient time to assess impact of intervention\n* Must have capacity to give informed consent\n* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions\n* Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment\n* Score of \\\u003C 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score \\>5, have clearance from dietitian\n\nExclusion Criteria:\n\n* History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)\n* Allergic reaction to any of the treatment agents\n* Any prior pelvic radiotherapy\n* Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy\n* History of GI perforation ≤12 months prior to enrollment\n* History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)\n* Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period\n* History of uncontrolled CHF defined as NYHA Class III or greater\n* Pre-existing grade ≥3 neuropathy\n* Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment\n* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)\n* Pregnant or breastfeeding\n* Currently perform overnight shift work \\>1 day\u002Fweek\n* Strictly adhering to a \\\u003C10-hour eating window on most days\n* Severe psychiatric, cognitive, or substance misuse disorders or social conditions that would interfere with adherence to study procedures.","ALL","21 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).\n\nA promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.",[25,26,27,28,29,30,31],"Rectal Cancer Stage II","Rectal Cancer Stage III","Breast Cancer Stage I","Rectal Cancer Stage IV","Breast Cancer Stage II","Breast Cancer Stage III","Solid Tumor Cancer",[33,34,35],"Time-restricted eating","Time restricted eating","Meal timing","RECRUITING","2026-06-19",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":19},"2026-07-07",{"date":44,"type":19},"2029-08-31",{"name":46,"class":47},"Fred Hutchinson Cancer Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":20,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100642722","phase-2-capecitabine-in-erher2-negative-breast-cancer-100642722","NCT07631052","Capecitabine in ER+\u002FHER2-negative Breast Cancer","Capecitabine for Targeted Eradication of aRising ctDNA Molecular Residual Disease in ER+\u002FHER2-negative Breast Cancer","Inclusion Criteria:\n\n* Male or female patients ≥ 18 years of age with histologically confirmed (by local assessment with ASCO\u002FCAP criteria), resected ER-positive\u002FHER2-negative stage I-III breast cancer\n* Evidence of MRD (positive test by the Pathlight assay) despite standard adjuvant therapy\n* No contraindications to capecitabine (including absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic capecitabine)\n* No clinical or radiographic evidence of recurrent or metastatic disease\n* Previous Therapy requirements: (i) Received at least 24 months of adjuvant endocrine therapy, including 6 months of an aromatase inhibitor and (i) Received at least 12 months of adjuvant CDK4\u002F6i if indicated, unless not tolerated or declined\n* ECOG performance status of 0-1.\n* Patient must have adequate organ function as determined by the following:\n\n  a. Renal function:\n* Serum creatinine \\\u003C 1.5 x ULN (upper limit of normal range) or a calculated creatinine clearance of \\> 50mL\u002Fmin using the Cockcroft-Gault formula\n\n  b. Bone marrow function (without hematopoietic growth factors or transfusion):\n* Absolute neutrophil count (ANC) \\> 1.0 x 109\u002FL\n* Hemoglobin \\> 90 g\u002FL or \\> 9g\u002FdL\n* Platelets \\> 75 x 109\u002FL\n\n  c. Liver function:\n* Total bilirubin ≤ 1.5 × ULN and \\\u003C 35 uMol\u002FL; OR total bilirubin \\>1.5 × ULN with indirect bilirubin \\\u003C 1.5 × ULN.\n* Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) \\\u003C 2.5 x ULN.\n* Female participants of childbearing potential must have a negative serum β-HCG test result at enrolment.\n* Female participants of childbearing potential must agree to use methods of contraception that are highly effective.\n* Male participants must agree to use methods of contraception that are highly effective.\n* The participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Signed written and voluntary informed consent.\n\nExclusion Criteria:\n\n* Prior therapy with capecitabine.\n* Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other non-invasive or indolent malignancy; other solid tumors treated curatively without evidence of recurrence for at least 3 years prior to study entry.\n* Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\n\n  1. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) \\\u003C6 months prior to screening,\n  2. Symptomatic chronic heart failure (e.g., New York Heart Association Class ≥ 2), history or current evidence of clinically significant cardiac arrhythmia and\u002For conduction abnormality \\\u003C6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia.\n  3. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100mmHg, despite current therapy.\n* Known positive serology for HIV (Human immunodeficiency virus) that is not currently controlled with antiretroviral therapy.\n* Has a known history of or is positive for active hepatitis B or hepatitis C unless adequate viral suppression is achieved. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit.\n* Impaired gastrointestinal function or disease that may significantly alter the absorption of capecitabine.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study.","18 Years",{"count":58,"type":19},15,[60],"PHASE2","This is a Phase 2 study for patients with resected Stage I-III HR+\u002FHER2-negative breast cancer with detected molecular residual disease (MRD+) following standard neo\u002Fadjuvant and locoregional therapy delivered with curative intent. In this study participants will be treated with capecitabine. Capecitabine will be administered orally at a dose of 500 mg 3 times daily for up to 12 months, or until the time of clinical recurrence, discontinuation due to toxicity, or withdrawal of consent. This study will have two stages, stage 1 would enroll up to 8 participants to clear the Minimal Residual Disease (MRD) and Stage 2 will enroll up to 5 participants. The purpose of this study is to determine if this study population would have a better outcome from receiving capecitabine rather than having no change in treatment if MRD is detected.",[63,27,29,30],"ER-positive, HER2-negative Breast Cancer","2026-06-09",{"date":66,"type":40},"2026-06-11",{"date":68,"type":19},"2026-06-30",{"date":70,"type":19},"2029-08-01",{"name":72,"class":47},"University Health Network, Toronto",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":48},"100572016","phase-2-memantine-and-exercise-to-improve-cognitive-function-and-modulate-biological-pathways-of-cognitive-decline-during-chemotherapy-in-breast-cancer-100572016","NCT06727773","Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer","Inclusion Criteria:\n\nIn order to participate in the study a subject must meet all of the eligibility criteria outlined below.\n\n* Female\n* Age ≥ 18 years at the time of consent.\n* Stage I-III Breast Cancer\n* Recommended chemotherapy\n* Enroll prior to 3rd cycle of chemotherapy\n* English-speaking\n\nExclusion Criteria:\n\n* Allergy to memantine\n* Previous chemotherapy (prior to the current regimen),\n* Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11\n* Myocardial infarction in the last 6 months\n* Cardiovascular or orthopedic limitations to exercise\n* Severe mental illness (i.e., schizophrenia or bipolar affective disorder)\n* Current alcohol or drug abuse\n* Inability to swallow capsules \\\u003C\u002F= 5mL\u002Fmin\n* CrCl \\\u003C\u002F= 5mL\u002Fmin","FEMALE",{"count":81,"type":19},90,[60],"This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real \\& Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.",[85,86,87,88,89,27,29,30],"Breast Cancer","Locally Advanced Breast Cancer","Cognitive Impairment","Cognitive Decline","Cognitive Change",[91,92,93,94,95],"chemotherapy","memantine","placebo-controlled","exercise","Get Real & Heel cancer exercise program","2026-05-01",{"date":98,"type":40},"2026-05-06",{"date":100,"type":40},"2025-08-19",{"date":102,"type":19},"2029-06-15",{"name":104,"class":47},"UNC Lineberger Comprehensive Cancer Center",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100587295","herbs--supplements-in-breast-cancer-usage-impact-and-personalized-approaches-for-diverse-populations-100587295","NCT06926530","Herbs & Supplements in Breast Cancer Usage, Impact, and Personalized Approaches for Diverse Populations","Navigating Herbs and Supplements in Breast Cancer: Usage, Impact, and Personalized Approaches for Diverse Populations","Inclusion Criteria:\n\n* Age: 18 years and older.\n* Breast cancer diagnosis at pathologic stage (I, II, and III)\n* Participants with regional lymph node involvement\n* Received Chemotherapy and\u002F or Endocrine therapy\n* Established patients followed by a medical oncologist at Cleveland Clinic Florida and Ohio\n* Able and willing to participate in the one-time survey.\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Prior history of cancer diagnosis\n* Unable or unwilling to participate in the survey\n* Distant Metastatic Disease",{"count":113,"type":19},240,"OBSERVATIONAL","This research study is enrolling participants diagnosed with breast cancer and receiving\u002Freceived chemotherapy and\u002For endocrine therapy. The study's primary objective is to assess the differences in the use of herbs and supplements among the populations served at Cleveland Clinic Florida and Ohio by administering a participant-reported questionnaire.",[85,27,29,30,117],"Breast Carcinoma",[119,120,121,122,123,124],"Complementary and Alternative Medicine","Alternative medicine","Herbs","Supplements","Complementary therapies","Holistic health","NOT_YET_RECRUITING","2026-04-27",{"date":128,"type":40},"2026-04-30",{"date":130,"type":19},"2026-06",{"date":132,"type":19},"2027-03",{"name":134,"class":47},"Case Comprehensive Cancer Center",2,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":79,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":20,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100609734","a-study-of-the-therabionic-p1-device-in-breast-cancer-100609734","NCT07218432","A Study of the TheraBionic P1 Device in Breast Cancer","A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting","Inclusion Criteria:\n\n* Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and\u002For PR (progesterone receptor) \\>1% and HER2 negative by immunohistochemistry \\[IHC\\] and\u002For fluorescent in situ hybridization \\[FISH\\]).\n* Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery.\n* Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection\n* Participant must have archival tissue available.\n* Participant must be a woman aged 22 years or older\n* Participant must be able to understand a written informed consent document and be willing to sign it\n* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session\n\nExclusion Criteria:\n\n* Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy\n* Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints\n* Participants that are taking any other investigational drugs\n* Participants that are pregnant or breastfeeding due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued\n* Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).\n* Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid\u002Fvitamin C, etc.) unless their medical treatment is discontinued at least one day prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study.\n* Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device\n* Participants with a known severe (e.g., anaphylactic) allergy to nickel.","22 Years",{"count":145,"type":19},24,[22],"The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.",[27,29,149,150,151],"Breast Cancer Stage IIIA","Hormone Receptor Positive Tumor","HER2-negative Breast Cancer","2026-04-16",{"date":154,"type":40},"2026-04-21",{"date":156,"type":19},"2026-10",{"date":158,"type":19},"2028-06-30",{"name":160,"class":47},"Barbara Ann Karmanos Cancer Institute",8,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":79,"minAge":170,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":20,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":196},"100623552","cryo-1-cryoablation-in-elderly-patients-with-early-stage-breast-cancer-100623552","NCT07398118","CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.","Treatment of Elderly Patients With Early Stage Breast Cancer (CRYO-1): The Efficacy of Cryoablation In The Elderly - A Phase II Multicentre, Feasibility Study.","CRYO-1","Inclusion Criteria:\n\n* Age ≥ 70 years\n* Histologically confirmed invasive breast cancer\n* Clinical stage cT1N0M0 based on mammography and ultrasound ER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR status\n* Presence of concurrent DCIS is allowed if limited to \\\u003C25% of the pre-NST biopsy, with no radiologic suspicion of an extensive component\n* Unifocal disease \\\u003C2 cm, well visualized on ultrasound, with a minimum distance of ≥5 mm from the skin, nipple and thoracic wall\n* Ability and willingness to comply with project requirements\n* Preoperative endocrine therapy is allowed\n* Written informed consent given by the subject\n\nExclusion Criteria:\n\n* Pure DCIS lesions without invasive component\n* Extensive calcifications on imaging suggestive of widespread disease\n* Invasive lobular carcinoma (as assessed by IHC)\n* Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive)\n* History of ipsilateral breast cancer or DCIS\n* Prior ipsilateral radiotherapy\n* Inability to communicate in Dutch or English language\n* Planned (e)migration or long-term stay abroad within one year after inclusion","70 Years",{"count":172,"type":19},61,[22],"This study looks at a new way to treat early-stage breast cancer in older adults using a freezing technique called cryoablation.\n\nOlder adults with early-stage breast cancer are usually treated with surgery or primary endocrine therapy (hormone therapy). While these treatments can be effective, they may also be burdensome. Surgery can lead to pain, slow recovery, or complications, and primary endocrine therapy often requires long-term medication and may cause side effects or stop working over time. Cryoablation may offer a less invasive treatment option.\n\nThe goal of this study is to find out whether cryoablation can be safely and successfully used as the main treatment for older adults with early-stage breast cancer. Cryoablation destroys the tumour by freezing it. The procedure is performed through the skin using imaging guidance and does not involve surgical removal of the tumour.\n\nParticipants in this study are adults aged 70 years or older who have a small breast tumour that has not spread to the lymph nodes. All participants receive cryoablation as a single treatment.\n\nAfter the procedure, participants are followed closely. Researchers will collect information on side effects, recovery, whether additional treatment is needed, and how participants experience the treatment. Quality of life will also be assessed.\n\nThis study is carried out in several hospitals. All participants must give written informed consent before taking part. The results of this study may help determine whether cryoablation could be a safe and practical treatment option for older adults with early-stage breast cancer and guide future research.",[27,176],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[178,179,180,181,182,183,184,185,186,187],"Cryoablation","Early-stage breast cancer","Non-curative","Elderly","Minimally invasive treatment","Breast tumour","Local tumour control","Feasibility study","Cryotherapy","Non-surgical treatment","2026-03-20",{"date":190,"type":40},"2026-03-23",{"date":192,"type":19},"2026-04-01",{"date":158,"type":19},{"name":195,"class":47},"St. Antonius Hospital",3,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":20,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":48},"100536733","phase-2-tart-cherry-juice-as-a-dietary-supplement-for-the-prevention-of-paclitaxel-induced-neuropathy-100536733","NCT06268665","Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","Inclusion Criteria:\n\n* Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.\n* Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.\n\n  * Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.\n  * Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.\n  * Concurrent use of immune checkpoint inhibitor therapy is allowed.\n  * (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.\n  * Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.\n* May participate concurrently in other cancer trials.\n* Must be able to complete questionnaires in English or Spanish.\n* Age ≥ 18 years old at the time of consent.\n* ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).\n* Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:\n\n  * A stable regimen of highly active anti-retroviral therapy (HAART)\n  * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n  * A CD4 count above 250 cells\u002FµL and an undetectable HIV viral load on standard PCR-based tests within the last year.\n* Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).\n* Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.\n* Currently taking anticoagulant medication.\n* Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements\u002Fmedications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E \\> 1,000 international units (IU) must be discontinued at the time of registration.\n* Patients may not use cold therapy gloves for chemotherapy induced neuropathy.\n* Known allergy to cherries.\n* Inability to swallow liquid.\n* Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).\n* Any condition that would prohibit the understanding or rendering of informed consent.\n* Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.",{"count":205,"type":19},86,[60],"This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.\n\nEligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).",[85,27,29,30,209,210,211,212,213,214,215,216,217,218,219,220,221,222,149,223,224,225,226,227,228,229,230,231,232,233,117,234,235,236,237,238,239],"Breast Cancer Stage IV","Invasive Breast Cancer","Ovarian Cancer","Ovarian Cancer Stage 1","Ovarian Cancer Stage II","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Ovarian Cancer Stage IA","Ovarian Cancer Stage IB","Ovarian Cancer Stage IC","Ovarian Cancer Stage 2","Ovarian Cancer Stage 3","Ovarian Cancer Stage IIIb","Ovarian Cancer Stage IIIC","Breast Cancer Invasive","Breast Cancer, Stage IA","Breast Cancer, Stage IB","Breast Cancer Stage IIA","Breast Cancer Stage IIB","Breast Cancer Stage IIIB","Breast Cancer Stage IIIc","Cancer, Breast","Tumors, Breast","Mammary Cancer","Mammary Carcinoma","Breast Neoplasm","Malignant Breast Neoplasm","Malignant Tumor of Breast","Cancer of Ovary","Ovary Cancer","Ovary Neoplasm","2026-03-02",{"date":242,"type":40},"2026-03-04",{"date":244,"type":40},"2024-08-15",{"date":246,"type":19},"2027-12",{"name":248,"class":47},"University of California, Davis",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":20,"phases":256,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":48},"100578102","phase-2-predicting-response-to-neoadjuvant-endocrine-therapy-neo-predict-100578102","NCT06806930","Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)","Inclusion Criteria:\n\n* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study\n* Be capable of signing and providing written consent in accordance with institutional and federal guidelines\n* Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast\n* Clinical stage 1 to 3 breast cancer\n* Candidate for surgical resection\n* Estrogen receptor \\> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.\n* HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.\n* Ability to take oral medication\n* Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff\n* Age ≥ 21 years\n\nExclusion Criteria:\n\n* Inability to comply taking NET\n* Inability to comply to study procedures",{"count":81,"type":19},[60],"The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called \"neoadjuvant\" treatment) affects breast cancer. The main questions the trial aims is answer are:\n\n1. How breast cancer responds to endocrine therapy given prior to surgery?\n2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C\n\nParticipants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:\n\n* receive endocrine therapy as part of regular care for breast cancer\n* consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor\n* participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed",[27,29,30,259],"Carcinoma, Breast",[261,262,263,264],"breast","cancer","HER2","carcinoma","2026-02-27",{"date":267,"type":40},"2026-03-03",{"date":269,"type":40},"2024-10-01",{"date":271,"type":19},"2028-10",{"name":273,"class":47},"George Washington University",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":20,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":48},"100508313","virtual-rehabilitation-for-cancer-survivors-100508313","NCT05898789","Virtual Rehabilitation for Cancer Survivors","Pragmatic Hybrid Type 1 Effectiveness-implementation (E-I) Trial of a Virtual Cancer Rehabilitation Program","Inclusion Criteria:\n\n* 1\\) Age 18 years or older\n* 2\\) Diagnosed with breast (stage 0-III), colorectal (stage I-III), head and neck (stage I-III), or lymphoma\u002Flymphoproliferative disorder (excluded: recurrent, refractory, progressive, received or planning to receive transplant)\n* 3\\) Completed a primary treatment (i.e. surgery and\u002For radiation and\u002For systemic therapy of any kind) within the last 24 months\n* 4\\) If patients received systemic therapy of a fixed duration with adjuvant\u002Fcurative intent, the main part should be completed, but patients are eligible if on primary, maintenance, or other adjuvant systemic therapy (e.g. eligible while on trastuzumab, immunotherapy, rituximab, oral endocrine or targeted therapy - ie ibrutinib). Indolent non-curative lymphoma patients are eligible if they have response to systemic therapy\n* 5\\) Communicate sufficiently in English to complete intervention and questionnaires\n* 6\\) Willing to be randomized and participate in the intervention and attend in-person or virtual assessments\n* 7\\) Internet access\n* 8\\) An indication for cancer rehabilitation (WHO-DAS score \\>5).\n\nExclusion Criteria:\n\n* 1\\) Impaired functional status that would preclude rehabilitation (PRFS \\>3)\n* 2\\) Indication of major depressive disorder (\\> or = to 20 on PHQ-9)\n* 3\\) Diagnosis of neurological disease or condition significantly limiting cognitive functioning, such as language or memory (e.g., Alzheimer's disease or other dementia, severe traumatic brain injury);\n* 4\\) Currently enrolled in another personalized and supervised exercise or rehabilitation program\n* 5\\) Conditions or current injuries which are not appropriate for distance based exercise (based on intake screening questions and as determined by physician\\*. \\*In cases where patient's indicate an existing higher risk condition (i.e high blood pressure, recent heart attach or unstable angina, spinal cord compression, recent deep vein thrombosis) or injury, the study team will contact the physician for medical approval and clearance to participate in the study will be required)",{"count":282,"type":19},388,[22],"Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer rehabilitation program: The study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of an 8-week multidimensional virtual cancer rehabilitation intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments on level of overall disability (primary outcome) and patient reported physical and social functioning, anxiety, work status, quality of life, and physiologic changes (secondary outcomes). The study team will conduct a multi-centre pragmatic randomized controlled trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and using the CIFR, the study team will identify potential factors that may affect successful implementation and integration of CaRE@Home in different cancer settings.",[286,287,288,289,27,29,30,290,291,292,293,294],"Breast Cancer, Stage 0","Colorectal Cancer Stage I","Head and Neck Cancer Stage I","Lymphoma","Colorectal Cancer Stage II","Colorectal Cancer Stage III","Head and Neck Cancer Stage II","Head and Neck Cancer Stage III","Lymphoproliferative Disorders","2026-02-23",{"date":297,"type":40},"2026-02-25",{"date":299,"type":40},"2023-07-07",{"date":301,"type":19},"2026-11-30",{"name":72,"class":47},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":20,"phases":313,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":48},"100593110","phase-1-a-phase-ibii-study-to-evaluate-multiple-combination-therapies-of-fwd1802-in-patients-with-erher2--bc-100593110","NCT07002177","A Phase Ib\u002FII Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+\u002FHER2- BC","An Open-label, Multicenter, Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subjects consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers.\n* Histologically or cytologically confirmed ER-positive\u002FHER2-negative locally advanced or metastatic breast cancer\n* Subjects must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal\u002Fperimenopausal women must agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment\n* Prior Therapy Requirements:Subjects must meet all of the following criteria:\n\n  1. Progression during\u002Fafter, intolerance to, ineligibility for, or refusal of standard therapy\n  2. Endocrine therapy history:\n\n     Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of maintenance therapy (no restriction on the number of prior endocrine therapy lines).\n  3. ≤2 prior lines of chemotherapy for ABC\n  4. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant\n  5. Everolimus combination arm: Prior CDK4\u002F6 inhibitor therapy requiredf) CDK4\u002F6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4\u002F6 inhibitor therapy;If only received adjuvant CDK4\u002F6 inhibitor therapy, recurrence must occur \\>12 months after treatment completion Note: Antibody-drug conjugates (ADCs) are classified as chemotherapy in this study.\n* Phase Ib: At least one evaluable lesion per RECIST v1.1, allowed subjects with osteolytic bone lesion(s) confirmed by CT\u002FMRI.Phase II: At least one measurable lesion per RECIST v1.1.\n\nSubject must have sufficient organ and bone marrow functions at screening.\n\nExclusion Criteria:\n\n* Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS) metastases；\n* History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of the investigational drug\n* Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary lymphangitis carcinomatosa. Prior intracavitary infusion therapy should have more than 14 days of stabilization,\n* Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant\n* Inadequate washout period for prior anticancer therapies.\n* Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm).\n* Subjects will be excluded if they meet any of the following:\n\n  1. Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment.\n  2. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic\n* Uncontrolled hypertension despite antihypertensive therapy, defined as:Systolic blood pressure (SBP) \\>150 mmHg OR Diastolic blood pressure (DBP) \\>95 mmHg.\n* Active cardiac disease or history of cardiac dysfunction","75 Years",{"count":312,"type":19},196,[314,60],"PHASE1","This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer",[317,27,29,318,319],"Metastatic Breast Cancer","Locally Advanced Breast Cancer (LABC)","ER+ Breast Cancer","2026-01-05",{"date":322,"type":40},"2026-01-07",{"date":324,"type":40},"2025-06-01",{"date":326,"type":19},"2028-11-01",{"name":328,"class":329},"Forward Pharmaceuticals Co., Ltd.","INDUSTRY",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":20,"phases":340,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":48},"100576578","phase-3-study-assessing-the-efficacy-and-safety-of-cannabidiol-oral-solution-for-joint-pain-of-adjuvant-endocrine-therapy-in-patients-with-early-breast-cancer-100576578","NCT06787118","Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer","Randomized, Double-blind, Placebo-controlled, 2x2 Cross Over Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer","PANDORA","Inclusion Criteria:\n\nGeneral inclusion criteria:\n\n1. Patient must understand, sign and date the written informed consent form (ICF) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedure as per protocol.\n2. Patient must be affiliated to a social security system or beneficiary of the same.\n3. Patient is ≥ 18 years-old at the time of study inclusion\n4. Patient has histologically confirmed invasive Stage I, II, III breast cancer.\n5. Patient has breast cancer that is positive for ER and\u002For PgR (nuclear staining of any intensity ≥ 10%)\n6. Patients should be taking a standard dose of one of the three approved AIs (i.e., anastrozole, exemestane, or letrozole) for at least 21 days, and not more than 36 months before trial registration; premenopausal patients are eligible if they are receiving AIs and ovarian function suppression (LHRH agonist).\n7. If indicated, patient has completed adjuvant and\u002For neoadjuvant chemotherapy according to the institutional guidelines, prior to randomization.\n8. If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines, prior to randomization.\n9. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n10. Patients should report an Interference pain score of ≥ 4 out of 10 on the Brief Pain Inventory (BPI, Appendix 2) within 7 days before registration.\n11. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n12. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative urine or serum pregnancy test (for β- hCG) within 14 days of randomization.\n13. Women of CBP, defined as all women physiologically capable of becoming pregnant, must be willing to use highly effective methods of contraception. It is recommended that sexually active males use a condom during intercourse and it is strongly advised that they do not father a child in this period (a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid). In all patients, contraception must continue during the trial treatment and for 3 months after stopping it, due to AI treatment. For women, highly effective contraception methods include:\n\n    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n    2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of bilateral oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment;\n    3. Placement of an intrauterine device (IUD). Notes:\n\n       * Use of oral (estrogen and progesterone), transdermal, injected or implanted hormonal methods of contraception (as well as hormonal replacement therapy) is not allowed in this trial.\n       * Women are considered of CBP unless: they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago.\n\n    Specific inclusion criteria for CBD use:\n14. Patient has adequate bone marrow and organ function as defined by the following local laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n    2. Platelets ≥ 100 × 109\u002FL\n    3. Hemoglobin ≥ 9.0 g\u002FdL\n    4. Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin by a Cockcroft-Gault formula.\n    5. Alanine transaminase (ALT) ≤ 1.5 × Upper Limit Normal (ULN)\n    6. Aspartate transaminase (AST) ≤ 1.5 × ULN\n    7. Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin ≤ 1.5 × ULN in patients with well documented Gilbert's Syndrome\n    8. International normalized ratio (INR) ≤ 1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to randomization).\n    9. Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements (the local laboratory value should be documented within normal limits after the correction) before randomization:\n\n       * Sodium\n       * Potassium\n       * Phosphorus\n       * Magnesium\n       * Total Calcium\n15. Standard 12-lead ECG values defined as the mean of the triplicate ECGs as locally assessed:\n\n    1. QTcF interval (using Fridericia's correction) at screening \\\u003C 450 msec\n    2. Mean resting heart rate 50-90 bpm (determined from the ECG)\n\nExclusion Criteria:\n\nGeneral exclusion criteria:\n\n1. Patient with distant metastases of breast cancer beyond regional lymph nodes (M1 disease according to AJCC 8th edition).\n2. Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and\u002For surgery (i.e. patient has toxicities attributed to prior anti-neoplastic therapy NCI CTCAE version 5.0 grade ≥1 at day of randomization, excluding alopecia and amenorrhea)\n3. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to randomization\n4. Patient has previous history of bone fracture or surgery of the affected knees, hands or both within 6 months prior to enrolment or known rheumatologic diseases;\n5. Patient has received opioids analgesics, systemic NSAIDs, topical analgesics, oral, intra-articular or intramuscular corticosteroids for treatment of joint pain or joint stiffness within 28 days prior registration;\n6. Patient has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n7. Patients with moderate (Child-Pugh B) hepatic impairment or severe (Child-Pugh C) hepatic impairment.\n8. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).\n9. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigators judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic anti-bacterial therapy, etc.) or limit life expectancy to ≤5 years.\n10. Participation in a prior interventional study and received trial treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.\n11. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breastfeed during the trial.\n12. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or under justice protection or under curatorship or unable of giving his consent\n\n    Specific exclusion criteria for CBD use:\n13. Patient with a known hypersensitivity to CBD or any of the excipients of CBD\n14. Previous serious adverse reaction to any cannabinoid product such as cannabinoid related psychosis, panic attack or delirium.\n15. Recreational or medicinal cannabis or synthetic cannabinoid based medications (including Sativex®) within 2 weeks before study entry\n16. Patient has previous or active psychological, psychiatric or central nervous system disorders, including epilepsy; schizophrenia or any other psychosis, severe borderline personality, patient with significant suicidal ideation.\n17. Patient takes drugs as clobazam, valproate, or levodopa;\n18. Patient has previous history of substance abuse or dependence to alcohol, opioids, amphetamines, benzodiazepines and other illicit stimulants.\n19. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n    1. History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry\n    2. Documented cardiomyopathy\n    3. Prior history of LVEF \\\u003C50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) which did not recover before study entry\n    4. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n       * Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia\n       * Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting trial treatment)\n       * Inability to determine the QTcF interval\n    5. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block)\n    6. Uncontrolled arterial hypertension with systolic blood pressure (SBP) \\> 160 mmHg",{"count":339,"type":19},130,[341],"PHASE3","Phase III, single-center, randomized, double-blind, placebo-controlled, 2x2 cross- over study, assessing the efficacy of CBD in patients with early HR+ BC, presenting aromatase inhibitor-related musculoskeletal pain",[27,29,30,344,345],"HR+ Breast Cancer","AI-related Musculoskeletal Pain","2025-11-24",{"date":348,"type":40},"2025-12-02",{"date":350,"type":19},"2025-12",{"date":352,"type":19},"2027-05",{"name":354,"class":47},"Gustave Roussy, Cancer Campus, Grand Paris",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":48},"100574685","a-new-tool-to-promote-patients-engagement-in-their-healthcare-process-100574685","NCT06762496","A New Tool to Promote Patient's Engagement in Their Healthcare Process","Development and Testing of a Patient's Decision Aid for Early Breast Cancer: a New Tool to Promote Patient's Engagement in Their Healthcare Process","Inclusion Criteria:\n\n* be 18 or older;\n* have received\u002Freceive diagnosis of resectable breast cancer in the early stage;\n* women treated or who will undergo oncological treatment for early breast cancer;\n* demonstrate the absence of psychopathological features.\n* be willing and able to provide written informed consent\u002Fassent for the trial\n\nExclusion Criteria:\n\n* breast cancer patients who showed physical or psychological issues, as well as cognitive impairments that prohibited their participation in this type of study;\n* neurological or psychiatric disorders that may compromise the patients' ability to take part in the study.\n* Distant metastases from breast cancer or locally advanced\u002Funresectable disease\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial",{"count":363,"type":19},180,"Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice.\n\nMain Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.",[117,27,29],[367,368,369],"early breast cancer","Patient Decision","engagement","2025-11-21",{"date":372,"type":40},"2025-11-28",{"date":374,"type":40},"2025-01-22",{"date":376,"type":19},"2027-01",{"name":378,"class":47},"European Institute of Oncology",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":20,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100537230","optimizing-surgical-decisions-in-young-adults-with-breast-cancer-100537230","NCT06275126","Optimizing Surgical Decisions in Young Adults With Breast Cancer","CONSYDER","Inclusion Criteria:\n\n* Female aged 18-44\n* New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Diagnosis of de novo Stage 4 breast cancer\n* Recurrent early-stage breast cancer\n* Bilateral breast cancer","44 Years",{"count":388,"type":19},800,[22],"The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.\n\nParticipants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients\u002Fsurgeons will also have their surgical consultation audio-recorded.",[392,27,29,30],"Breast Cancer Stage 0","2025-09-02",{"date":395,"type":40},"2025-09-09",{"date":397,"type":40},"2024-03-13",{"date":399,"type":19},"2027-08-31",{"name":401,"class":47},"Weill Medical College of Cornell University",4,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":20,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":48},"100456139","medical-imaging-and-thermal-treatment-for-breast-tumors-using-harmonic-motion-imaging-hmi-100456139","NCT05219695","Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)","Inclusion Criteria:\n\n* Women age ≥18\n* Patients with fibroadenoma (benign tumor) or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes)\n* Scheduled to receive surgical resection of the tumor by the clinical care team (ideal target lesion upper boundary should be deeper than 1 cm below the skin, and the ideal size of the lesion should be 2-5 cm in diameter)\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patients with breast implants\n* Patients with a history of laser or radiation therapy to the targeted breast\n* Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor (other than surgery) as part of clinical care",{"count":410,"type":19},36,[22],"The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.",[414,27],"Fibroadenoma","2025-05-28",{"date":417,"type":40},"2025-05-31",{"date":419,"type":40},"2022-01-19",{"date":421,"type":19},"2026-05",{"name":423,"class":47},"Columbia University",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":431,"sex":79,"minAge":56,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":48},"100589150","role-of-triggering-receptor-expressed-on-myeloid-cells-trem-1-as-a-novel-biomarker-in-human-epidermal-growth-factor-receptor--2-her-2-negative-breast-cancer-a-molecular-and-clinical-study-100589150","NCT06950671","Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study","Role of TREM-1 as a Novel Biomarker in HER-2 Negative Breast Cancer: a Molecular and Clinical Study","Inclusion Criteria:\n\n* female patient aged \\\u003C 18 yrs. old\n* histological proven breast cancer\n* HER-2 negative (hormonal positive or triple negative)\n* planned to receive neo-adjuvant therapy\n* complete clinical, radiological and therapeutic data\n\nExclusion Criteria:\n\n* metastatic breast cancer\n* HER-2 positive\n* incomplete clinical, radiological or therapeutic data",true,"80 Years",{"count":48,"type":19},"Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative. (2) Most breast cancer cases can be cured by multimodality treatment, although cure rates vary by clinical stage, subtype and the clinical behavior of cancer which affected by the composition of pro- and anti-tumor immune mediators within the tumor microenvironment. (3, 4) Immune gene signatures in breast tumors -that comprise genes with specialized roles in immune biology- Significantly, have been shown to correlate with patient survival outcomes. (5-8)chemotherapy responsiveness. (7, 9), and more recently, response to immunotherapies.(10-12)One such candidate, the gene encoding Triggering Receptor Expressed on Myeloid Cells (TREM)-1, which emerged as a robust therapy predictive and prognostic marker. TREM1 encodes a type I trans-membrane receptor of the Ig superfamily expressed by effectors of innate immunity including neutrophils, monocytes and macrophages. The TREM-1 receptor is known to augment inflammatory signaling in response to infectious pathogens by promoting release of cytokines that modulate the activation, recruitment and survival of myeloid and lymphoid cells. (13) In this study we hope to gain a better understanding of TREM-1 clinical and molecular relevance in HER2 negative BC either triple negative or hormonal positive which represent significant subset that lack target therapeutic options, evaluating its effect as predictive and prognostic marker and so the potential implications for patient management.",[27,29,30,223],[437],"TREM-1 in non metastatic HER-2 negative breast cancer","2025-04-27",{"date":440,"type":40},"2025-04-30",{"date":442,"type":19},"2025-09-15",{"date":444,"type":19},"2029-09",{"name":446,"class":47},"Rahma Esam Salama Esawi",{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100552671","optimaloptimisation-of-treatment-for-patients-with-low-stage-triple-negative-breast-cancer-with-high-stromal-tumor-infiltrating-lymphocytes-100552671","NCT06476119","OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes","OPTImaL","Inclusion Criteria:\n\n* Female or male patients;\n* \\>=18 years;\n* Written informed consent;\n* TNBC (defined as: invasive carcinoma; ER\u002FPR expression 0-9%; Human Epidermal Growth Factor Receptor 2 \\[HER2\\] negative \\[0, 1+ or 2+ on immunohistochemistry, without HER2 amplification on in-situ hybridization\\]) on the diagnostic biopsy and the surgical specimen;\n* Pathological stage I TNBC (according to the TNM staging 8th edition):\n\n  * pT1a\u002Fb\u002Fc (≤2 cm), confirmed by an invasive component of ≤2 cm on the surgical specimen (microinvasive disease \\[pT1mi, ≤1 mm) is not allowed);\n  * pN0, confirmed by absence of malignant cells in the sentinel lymph node or any other lymph node after surgery (isolated tumor cells \\[N0(i+)\\] are not allowed);\n* No evidence of nodal or distant metastases (cN0M0) on pre and\u002For postoperative imaging examinations (performed following local\u002Fnational guidelines, but must include an 18F-fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography \\[18F-FDG-PET\u002FCT, at least from skull base to upper legs\\] or computed tomography \\[CT\\] of neck\u002Fchest\u002Fabdomen\u002Fpelvis \\[CT only if 18F-FDG-PET\u002FCT would not be available; 18F-FDG-PET\u002FCT mandatory in the Netherlands\\]);\n* sTIL score of ≥50% for patients ≥40 years at the time of TNBC diagnosis and ≥75% for patients \\\u003C40 years at the time of TNBC diagnosis on an H\\&E FFPE tissue slide on the surgical specimen, according to International Immuno-Oncology Biomarker Working Group on Breast Cancer (formerly International TILs Working Group) guidelines, by local and central review\n* Has undergone curative breast surgery (breast-conserving surgery or mastectomy and surgical axillary staging \\[including at least sentinel lymph node procedure\\]);\n* Absence of recurrence between curative breast surgery and expression of patient preference;\n* Eligible for radiotherapy (if indicated).\n\nExclusion Criteria:\n\n* Prior disease history of invasive and\u002For non-invasive breast cancer, or ongoing treatment for invasive and\u002For non-invasive breast cancer;\n* Multifocal, multicentric or bilateral breast cancer at the time of screening;\n* Administration of neoadjuvant systemic therapy;\n* Presence of lymphovascular invasion on the diagnostic biopsy and\u002For the surgical specimen;\n* Other invasive malignancy within 5 years prior to inclusion, with the exception of ade-quately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤6 prostate cancer;\n* Uncontrolled severe illness or medical condition;\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.",{"count":455,"type":19},490,"The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment. In addition, the investigation looks at whether the omission of chemotherapy ensures a better quality of life. Participants decide, in consultation with their treating physician, whether they choose to be treated with adjuvant chemotherapy or not.",[27,458],"Triple Negative Breast Cancer (TNBC)",[460],"High (stromal Tumor-Infiltrating-Lymphocytes) sTIL score","2025-04-17",{"date":463,"type":40},"2025-04-23",{"date":465,"type":40},"2025-04-15",{"date":467,"type":19},"2034-09-15",{"name":469,"class":47},"The Netherlands Cancer Institute",28,{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":20,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":48},"100587681","ways-of-retaining-the-inframammary-fold-in-implant-based-breast-surgery-100587681","NCT06931548","Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery","Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery Using Polytetrafluoroethylene (PTFE) Mesh or Allogeneic Dura Mater Graft","Inclusion Criteria:\n\n* White women;\n* Breast cancer stage 0-II;\n* Indications for breast reconstruction;\n* Consent to participate in the study and photographic documentation.\n\nExclusion Criteria:\n\n* Non-white women;\n* Breast cancer stage III-IV;\n* Tubular breast;\n* Mental and cognitive health disorders;\n* Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation);\n* Patient refusal to participate in the study at any stage.",{"count":18,"type":19},[22],"There is currently no consensus on the \"gold standard\" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control.\n\nPatients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer.\n\nThe primary questions this study aims to answer are:\n\n* What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation.\n* How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction?\n* What is the patient satisfaction rate with the surgical results?\n\nPatients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will stabilize the projections of the inframammary fold and breast implant.\n\nAfter the surgery, all minor and major complications will be recorded for 6 months. For this, both physical examination and radiological diagnostic methods will be used, including breast ultrasound and MRI with contrast. Revision surgeries will be performed if necessary.\n\nProjections of the inframammary fold and breast implant will also be measured in order to determine the effectiveness of the compared techniques.\n\nPatients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire to determine satisfaction with the surgical outcome.\n\nThe results of the study will help the professional community to determine the most effective method of Implant-based Breast reconstruction and will be published in peer-reviewed scientific journals.",[27,29,482],"In Situ Breast Cancer",[484,485,486],"implant-based breast reconstruction","breast cancer","PTFE mesh",{"date":461,"type":40},{"date":489,"type":40},"2022-03-01",{"date":491,"type":19},"2026-02",{"name":493,"class":47},"Branch Office of \"Hadassah Medical Ltd\"",{"id":495,"slug":496,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":20,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":48},"100461448","phase-2-adjuvant-chemoradiation-and-biomarkers-of-response-in-high-risk-breast-cancer-100461448","NCT05288777","Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer","A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer","Breast53","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 or older\n4. Diagnosis of stage I-IIIB breast cancer\n5. Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and\u002For mastectomy)\n6. Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection\n7. Candidate for adjuvant chemoradiation as part of standard clinical care\n8. Planned initiation of radiation within 12 weeks of their final oncologic surgery\n9. ECOG performance status ≤2\n10. Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)\n11. Adequate organ function per the following criteria within 21 days before the start of treatment. If a laboratory value required for study eligibility does not meet the below requirements, the value may be retested.\n\n    * Absolute neutrophil count ≥1.5 k\u002FuL\n    * Platelets ≥100 k\u002FuL\n    * Hemoglobin ≥ 10 g\u002FdL\n    * Serum Creatinine ≤ 1.5 x ULN\n    * Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed).\n    * AST and ALT ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n12. For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 6 months after the end of chemoradiation administration or until advised by their medical oncologist\n13. Agreement to adhere to Lifestyle Considerations throughout study duration\n14. Subjects taking warfarin and plan to receive capecitabine will need their anticoagulant management assessed before starting treatment.\n\nExclusion Criteria:\n\n1. Had a mastectomy with expander placement or immediate reconstructions\n2. Diagnosed with systemic lupus\n3. Diagnosed with scleroderma\n4. Diagnosed with a genetic mutation associated with increased sensitivity to radiation (e.g. ataxia-telangectasias (AT)). AT heterozygotes without known radiation sensitivity may be included.\n5. Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration.\n6. Pathologic evidence of metastatic disease, or strong clinical\u002Fradiological evidence of metastatic disease, at the investigator's judgment.\n7. Pregnancy or lactation\n8. Incarceration\n9. Presence of cardiac pacemaker on side of the body that is being treated unless the pacemaker can be moved prior to treatment.\n10. Anthracycline exposure exceeding a cumulative doxorubicin dose of 264 mg\u002Fm2 (240 mg\u002Fm2 plus a 10% threshold)\n11. Known allergic reactions to components of capecitabine or T-DM1\n12. Known DPD deficiency for patients prescribed capecitabine\n13. Febrile illness within a week of starting treatment\n14. Incomplete healing of chest wall or breast in the treatment field within 12 weeks from surgery.\n15. Known HIV or active hepatitis.\n16. Unwilling to discontinue endocrine therapy if currently taking endocrine therapy.",{"count":503,"type":19},45,[60,341],"The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and\u002For mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.",[85,27,29,30],[508,509,510,511,512,513,514,515,516,517],"Radiation","Chemoradiation","Chemotherapy","Chemo","T-DM1","xeloda","capecitabine","Adjuvant","Combination treatment","trastuzumab",{"date":519,"type":40},"2025-04-18",{"date":521,"type":40},"2022-07-11",{"date":523,"type":19},"2029-12",{"name":525,"class":47},"University of Virginia",{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":20,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":542,"locationsCount":48},"100516614","evaluation-of-radiobiological-effects-in-skin-toxicities-for-breast-cancer-patients-with-pencil-beam-scanning-proton-therapy-100516614","NCT06006806","Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy","Inclusion Criteria:\n\n* The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.\n* Patients must be equal to or greater than 18 years old.\n* The patient must have stage 0, I, II, or III breast cancer\n* On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma of the breast\n* Surgical treatment of the breast must have been lumpectomy or mastectomy\n* Patients must have an estrogen receptor (ER) analysis performed on the primary tumor\n* Progesterone (PgR) analysis is desired but not mandatory\n* No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment\n\nExclusion Criteria:\n\n* Stage IV breast cancer\n* Non-epithelial breast malignancies such as sarcoma or lymphoma\n* Paget's disease of the nipple\n* Prior breast or thoracic radiation therapy (RT) for any condition.\n* Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.\n* Pregnancy or lactation\n* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.",{"count":18,"type":19},[22],"This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called \"Spot Delete\" to see if it can reduce skin reactions for breast patients treated with PBS. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The \"Spot Delete\" method prevents protons from stopping in the skin, which is thought to cause skin redness.",[85,29,30,27],"2025-04-07",{"date":538,"type":40},"2025-04-08",{"date":299,"type":40},{"date":541,"type":19},"2030-07-07",{"name":543,"class":47},"Covenant Health Cancer Center",{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":20,"phases":553,"briefSummary":554,"conditions":555,"keywords":558,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":4},"100547394","phase-3-improvement-of-quality-of-life-through-supportive-treatments-for-hormone-therapy---related-symptoms-in-patients-with-early-breast-cancer-100547394","NCT06407401","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer; A Pragmatic Randomized Controlled Trial","Inclusion criteria:\n\n* Female (both pre- and postmenopausal) or male patients\n* Age ≥18 years\n* Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III\n* Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction\n* Present endocrine therapy related MSK pain (arthralgia and\u002For bone pain and\u002For myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit:\n\n  * Grade 2: moderate pain; limiting instrumental activities daily living (ADL)\n  * Grade 3: severe pain; limiting activities self-care ADL\n* Previous chemotherapy is allowed if completed at least 3 months before enrolment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Adequate organ function\n* Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)\n* Before patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n\n* Patients of childbearing \u002F reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment.\n\nExclusion criteria:\n\n* Current history of moderate\u002Fsevere depression and\u002For anxiety, both defined as grade≥2 CTCAE V5.0\n* History of suicide-related events\n* Current use of diuretics, antidepressants and\u002For phytoestrogens\n* Current use of prescribed or natural medicines with known interactions with furosemide and\u002For duloxetine\n* Contraindications to duloxetine:\n\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Uncontrolled hypertension\n  * Hepatic impairment Child Pugh Class B or C\n* Contraindications to furosemide:\n\n  * Symptomatic hypotension, hypovolemia, or dehydration\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Severe hypokalaemia and\u002For severe hyponatremia\n  * Addison's disease\n  * Porphyria\n* Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.\n* Participation in another interventional study with drugs.",{"count":552,"type":19},399,[341],"This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+\u002FHER2- early breast cancer with joint, muscle and\u002For bone pain caused by the endocrine therapy.\n\nThe purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and\u002For bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).",[319,151,27,29,30,556,557],"Drug-Related Side Effects and Adverse Reactions","Musculoskeletal Pain",[559],"Quality of Life","2024-11-04",{"date":562,"type":40},"2024-11-05",{"date":564,"type":19},"2024-12",{"date":566,"type":19},"2028-11-30",{"name":568,"class":569},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"id":571,"slug":572,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":79,"minAge":56,"maxAge":170,"enrollmentInfo":576,"targetDuration":4,"studyType":20,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":48},"100505429","phase-2-adjuvant-pyrotinib-and-capecitabine-for-her2-positive-micro-invasive-breast-cancer-100505429","NCT05861271","Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer","Inclusion Criteria:\n\n1. Women aged 18-70;\n2. The pathology of early breast cancer after surgery is T1micN0: histologically confirmed that the longest diameter of invasive cancer does not exceed 1mm or the maximum diameter of multiple invasive lesions is less than 1mm, and the lymph node is negative (N0);\n3. The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection.\n4. Hormone receptor negative (HR-) is defined as ER, PR expression is \\\u003C1%; Hormone receptor positivity (HR+) is defined as ER and\u002For PR expression ≥1%.\n5. For patients with both invasive lesions, if both lesions are HER-2 positive, they can be enrolled.\n6. ECOG score≦ 1 point;\n7. No obvious dysfunction of major organs;\n8. Blood routine: ANC ≥1.5×109\u002FL, PLT≥100×109\u002FL, blood Hb≥ 9 g\u002Fdl (no transfusion within 14 days);\n9. Liver function: total bilirubin ≤1.25×ULN; AST and ALT \\\u003C2.5×ULN;\n10. Renal function: creatinine clearance ≥ 50 mL\u002Fmin, blood creatinine ≤ 1.5 ×ULN;\n11. Cardiac function: ECG is generally normal, QTc\\\u003C 470 ms; LVEF \\> 50%;\n12. contraception during treatment for women of childbearing age;\n13. No history of other malignant tumors in the past 5 years;\n14. With the consent of the person and signed the informed consent form, or signed by the patient's legal representative with the authorization of the patient.\n15. Can be followed up and good compliance.\n\nExclusion Criteria:\n\n1. The maximum size of the infiltrate is more than 1mm in diameter or the axillary lymph node is positive\n2. HER2 negative: immunohistochemical HER2-,+; Immunohistochemical HER2+ while FISH has no amplification;\n3. Patients who have received neoadjuvant therapy or any other form of systemic therapy or local therapy other than surgery, including chemotherapy, targeted, radiotherapy, or endocrine therapy, prior to enrollment\n4. History of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;\n5. Metastasis of any part;\n6. Pregnant or lactating women, women of childbearing age who cannot be effectively contraceptives;\n7. Patients who participate in other clinical trials at the same time;\n8. Severe organ function (heart, lung, liver and kidney) insufficiency, LEVF \\\u003C 50% (ultracardiogram); severe cardiovascular and cerebrovascular diseases (such as: unstable angina, chronic heart failure, uncontrollable hypertension \\>150\u002F90mmgh, myocardial infarction or cerebrovascular accident) within 6 months before enrollment; diabetics with poor glycemic control; Patients with severe hypertension;\n9. Severe or uncontrolled infection;\n10. Those who have a history of psychotropic substance abuse and cannot quit or have a history of mental disorders;\n11. Patients who are judged by the investigator to be unsuitable to participate in this study.",{"count":577,"type":19},1008,[60],"For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.",[27],"2024-03-21",{"date":583,"type":40},"2024-03-22",{"date":585,"type":40},"2023-06-01",{"date":587,"type":19},"2028-07-01",{"name":589,"class":47},"Fudan University"]