[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-stage-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-stage-iii":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,49,97,120,146,170,199,228,252,284,335,360,388,412,436,460,483,505,537,554,579,607],{"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":60,"conditions":61,"keywords":73,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100610263","a-study-of-meaning-centered-therapy-for-mexican-adults-with-advanced-cancer-100610263","NCT07225309","A Study of Meaning-Centered Therapy for Mexican Adults With Advanced Cancer","Trial of Meaning Centered Psychotherapy for Mexican Patients With Advanced Cancer","Patient Eligibility Criteria:\n\nA patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener and suicide risk assessment.\n\nInclusion Criteria:\n\nEMR Criteria\n\n\\- Documentation of Disease\n\n* Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis)\n\n  * Definition of Disease \\[or Measurable Disease\\]\n* Diagnosed with stages III or IV\n\n  * Prior Treatment\n* Receiving ambulatory care at INCan\n\nSelf-Report Criteria\n\n* Age ≥ 18 years\n* Able to read and communicate in Spanish determined by the question: \"Can you read and communicate in Spanish? Yes\u002FNo\"\n* Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention\n* Providing care (or services) to Mexican cancer patients at INCan\n* Has access to internet and an electronic device\n* Agrees to be audio-recorded\n\nExclusion Criteria:\n\nEMR Criteria\n\n* Prior Treatment\n\n  * Received psychological or psychiatric care at INCan in the last 3 months\n  * In the judgment of the treating physician, protocol investigators, and\u002For study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For study participation\n  * Diagnosed with a serious psychiatric condition\n\nSelf-Report Criteria\n\n* Received psychological or psychiatric care outside of INCan in the last 3 months\n* Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale\n* Too ill to participate determined by the question: \"Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?\"\n\nProvider Eligibility Criteria:\n\nInclusion Criteria Self-Report Criteria\n\n* Age ≥ 18 years\n* Able to read and communicate in Spanish determined by the question: \"Can you read and communicate in Spanish? Yes\u002FNo\"\n* Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention\n* Providing care (or services) to Mexican cancer patients at INCan\n* Has access to internet and an electronic device\n* Agrees to be audio-recorded","18 Years",{"count":58,"type":19},300,[22],"The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Investigators also want to learn what participants and providers think about the therapy, including how the therapy is designed, outside factors, available resources, and how the people involved affect how well MCP-L works.",[62,63,64,65,30,66,67,68,69,70,71,72],"Breast Cancer","Prostate Cancer","Colorectal Cancer","Thyroid Cancer","Breast Cancer Stage IV","Prostate Cancer Stage III","Prostate Cancer Stage IV","Colorectal Cancer Stage III","Colorectal Cancer Stage IV","Thyroid Cancer Stage III","Thyroid Cancer Stage IV",[74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Breast cancer","Breast cancer Stage III","Breast cancer Stage IV","Prostate cancer","Prostate cancer Stage III","Prostate cancer Stage IV","Colorectal cancer","Colorectal cancer Stage III","Colorectal cancer Stage IV","Thyroid cancer","Thyroid cancer Stage III","Thyroid cancer Stage IV","25-240","Memorial Sloan Kettering Cancer Center","2026-06-18",{"date":90,"type":40},"2026-06-22",{"date":92,"type":40},"2026-05-01",{"date":94,"type":19},"2029-04-13",{"name":87,"class":47},2,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":20,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"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.",{"count":105,"type":19},15,[107],"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.",[110,27,29,30],"ER-positive, HER2-negative Breast Cancer","2026-06-09",{"date":113,"type":40},"2026-06-11",{"date":115,"type":19},"2026-06-30",{"date":117,"type":19},"2029-08-01",{"name":119,"class":47},"University Health Network, Toronto",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":20,"phases":129,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100571500","a-study-of-language-interpretation-solutions-for-people-with-breast-cancer-100571500","NCT06721065","A Study of Language Interpretation Solutions for People With Breast Cancer","RSMI HEALS (Health Equity Advances Through Language Solutions) (AI)","Inclusion Criteria:\n\nPhase I Patients\n\n* Age \\>=18 years (per EMR)\n* Preferred language for healthcare is Spanish or Mandarin (per self-report)\n* Limited English Proficient; cannot speak English \"very well\" (per self-report)\n* Diagnosis of breast cancer or gastrointestinal (per EMR)\n* Will be visiting MSK oncology teams for the first or second appointment (per EMR)\n* Agrees to be audio-recorded (per self-report)\n\nPhase 1 Providers\n\n* Breast or gastrointestinal cancer provider who sees patients (e.g., breast or gastrointestinal oncologists, advanced practice providers, and\u002For nurses)\n* Does not speak Spanish and\u002For Mandarin; providers who speak one language and not the other may participate (e.g., speaks Spanish but not Mandarin) (per self-report)\n* Agrees to be audio-record (per self-report) Phase 2 (clinic staff only; patient participants will be drawn from Phase 1)\n* Is a staff member who works\u002Fworked in one of the study clinic sites during the period of Phase 1 RCT study activities\n* Agrees to be audio-recorded (per self-report)\n\nExclusion Criteria:\n\nPhase 1 Patients\n\n* Has significant psychiatric disturbance (i.e., acute psychiatric symptoms) sufficient to preclude completion of the assessments, interviews, or informed consent (per EMR, patient's care team, or study team)\n* Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For data collection (per EMR, patients, care team, or study team)\n\nPhase I Providers\n\n* None\n\nPhase 2 (clinic staff only; Phase 1 patient participants follow above criteria)\n\n* None",{"count":128,"type":19},700,[22],"The study will be conducted in 2 overlapping phases. In Phase 1, there will be a 3-arm randomized controlled trial of Remote Simultaneous Medical Interpreting\u002FRSMI (Arm 1), versus Remote Consecutive Medical Interpreting\u002FRCMI (Arm 2) and versus Remote Consecutive Video Medical Interpreting\u002FRCVI (Arm 3) in breast cancer outpatient clinical encounters with Spanish- and Mandarin-speaking patients with Limited English Proficiency\u002FLEP (Stages II and III disease) and English- speaking providers (who do not speak Spanish\u002FMandarin). In Phase 2, there will be a sequential mixed-methods explanatory, multi-stakeholder process evaluation to gather implementation potential data.",[62,29,30],[62,29,30,133,134,135,87,136],"Language Interpretation","Spanish","Mandarin","24-350","2026-05-11",{"date":139,"type":40},"2026-05-12",{"date":141,"type":40},"2024-12-02",{"date":143,"type":19},"2029-12-02",{"name":87,"class":47},8,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":153,"minAge":56,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":48},"100506705","evaluating-and-monitoring-immune-and-clinical-responses-in-early-stage-triple-negative-breast-cancer-undergoing-neoadjuvant-chemo-immunotherapy-with-pembrolizumab-100506705","NCT05877859","Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab","Inclusion Criteria:\n\n* Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer\n* Estrogen receptor IHC expression ≤10%; progesterone receptor IHC expression ≤ 10%; HER2 negative\n* HER2 negativity is defined as either of the following by local laboratory assessment:\n* IHC 0, 1+, or 2+ and In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C2.0 or single probe average HER2 gene copy number \\\u003C4 signals\u002Fcell)\n* No prior chemotherapy, endocrine therapy, or immunotherapy\n* Willingness and ability of the subject to comply with scheduled visits, standard of care drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study\n* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.\n* Patients on steroid medications (i.e. prednisone, dexamethasone, etc.) that are not part of the standard pre-medications and\u002For take home medications that are included as a part of medication regimen for the pre-operative chemo-immunotherapy described in the study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.",true,"FEMALE",{"count":155,"type":19},10,"OBSERVATIONAL","This research study is a prospective, single arm, pilot study, designed to evaluate the correlation between the immune and clinical responses of subjects with untreated Stage II-III triple negative breast cancer (TNBC) undergoing standard of care neoadjuvant chemo- immunotherapy.",[159,29,30,160],"Breast Cancer Triple Negative","Breast Cancer Invasive","2026-05-05",{"date":163,"type":40},"2026-05-07",{"date":165,"type":40},"2023-05-30",{"date":167,"type":19},"2028-02-20",{"name":169,"class":47},"Emory University",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":153,"minAge":56,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":20,"phases":178,"briefSummary":179,"conditions":180,"keywords":185,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"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",{"count":177,"type":19},90,[107],"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.",[62,181,182,183,184,27,29,30],"Locally Advanced Breast Cancer","Cognitive Impairment","Cognitive Decline","Cognitive Change",[186,187,188,189,190],"chemotherapy","memantine","placebo-controlled","exercise","Get Real & Heel cancer exercise program",{"date":192,"type":40},"2026-05-06",{"date":194,"type":40},"2025-08-19",{"date":196,"type":19},"2029-06-15",{"name":198,"class":47},"UNC Lineberger Comprehensive Cancer Center",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":96},"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":207,"type":19},240,"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.",[62,27,29,30,210],"Breast Carcinoma",[212,213,214,215,216,217],"Complementary and Alternative Medicine","Alternative medicine","Herbs","Supplements","Complementary therapies","Holistic health","NOT_YET_RECRUITING","2026-04-27",{"date":221,"type":40},"2026-04-30",{"date":223,"type":19},"2026-06",{"date":225,"type":19},"2027-03",{"name":227,"class":47},"Case Comprehensive Cancer Center",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":153,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":20,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":96},"100631654","evaluation-of-the-efficacy-of-biobran-rice-bran-arabinoxylan-in-supporting-breast-cancer-chemotherapy-100631654","NCT07503496","Evaluation of the Efficacy of Biobran (Rice Bran Arabinoxylan) in Supporting Breast Cancer Chemotherapy","Inclusion Criteria:\n\n* Breast cancer stage I-III\n\nExclusion Criteria:\n\n* pregnant, lactation, breast recurrence, mental disease, autoimmune disease over hte past 5 years, people who take plant or fungal polysaccharide health supplements","20 Years","65 Years",{"count":237,"type":19},96,[22],"This study aims to evaluate the potential supportive effects of rice bran arabinoxylan compound (Biobran) in patients with breast cancer receiving paclitaxel and doxorubicin chemotherapy. The study will assess chemotherapy-related side effects, quality of life, tumor size, tumor antigens, and routine blood test parameters over 24 weeks of treatment.",[241,242,30],"Breast Cancer Stages I","Breast Cancer Stages II","2026-03-25",{"date":245,"type":40},"2026-03-31",{"date":247,"type":40},"2025-04-07",{"date":249,"type":19},"2026-08-31",{"name":251,"class":47},"China Medical University Hospital",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":20,"phases":262,"briefSummary":264,"conditions":265,"keywords":269,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100630362","phase-3-pembrolizumab-adjuvant-in-patients-with-early-stage-triple-negative-breast-cancer-with-residual-disease-after-neoadjuvant-pembrolizumab-plus-chemotherapy-100630362","NCT07486687","Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy","PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial","PLANET","Inclusion Criteria:\n\n1. Male or female, ≥18 years of age on day of signing informed consent\n2. Stage II or III TNBC prior to the start of neoadjuvant treatment\n\n   1. Locally assessed stage II or III TNBC according to the primary tumor (T) and regional lymph node (N) staging as per the American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8\n   2. Locally assessed estrogen receptor (ER) and\u002For progesterone receptor (PR) expression \\\u003C10% and HER2-negative according to the ASCO-CAP guideline1\n3. The patient has received neoadjuvant treatment with chemotherapy (containing at least anthracyclines and taxanes) and pembrolizumab, with a minimum of two 6-weekly (or four 3-weekly) cycles of pembrolizumab\n4. The patient underwent breast surgery ≤12 weeks prior to inclusion in the study\n5. The patient is scheduled to start standard of care adjuvant treatment with capecitabine or olaparib (pending reimbursement), based on non-pCR after neoadjuvant treatment, defined as RCB score \\>02\n6. World Health Organization (WHO) performance status 0-2\n7. Adequate organ function, as assessed ≤30 days prior to the screening:\n\n   1. Absolute neutrophil count (ANC) ≥1,000\u002Fmm3 (1.0 x 10e9 \u002FL)\n   2. Platelets ≥50,000\u002Fmm3 (50 x 10e9 \u002FL);\n   3. Estimated creatinine clearance ≥ 30 mL\u002Fmin as calculated using the method standard for the institution;\n   4. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease);\n   5. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN\n8. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication\n9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n10. Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national\u002Flocal regulations\n\nExclusion Criteria:\n\n1. Contra-indications for any of the study drugs\n2. Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago\n3. The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n4. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study",{"count":261,"type":19},1000,[263],"PHASE3","The phase III, multicenter, pragmatic PLANET trial aims to evaluate the benefit and safety of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) in triple negative breast cancer (TNBC) patients with residual disease (non-pCR) after neoadjuvant chemotherapy and pembrolizumab. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinical trial). In addition to the randomized trial, a registry will be set up, in which patients who reach pCR (and therefore, do not receive adjuvant treatment) will be registered and followed.",[266,267,268,29,30],"Triple Negative Breast Cancer (TNBC), Early Setting","Early Stage Triple-Negative Breast Carcinoma","Triple -Negative Breast Cancer",[270,271,272,74,273,274],"Immunotherapy","Pembrolizumab","Triple negative breast cancer","TNBC","Adjuvant","2026-03-17",{"date":277,"type":40},"2026-03-20",{"date":279,"type":19},"2026-04",{"date":281,"type":19},"2036-04",{"name":283,"class":47},"The Netherlands Cancer Institute",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":20,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"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":292,"type":19},86,[107],"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).",[62,27,29,30,66,296,297,298,299,300,301,302,303,304,305,306,307,308,309,160,310,311,312,313,314,315,316,317,318,319,210,320,321,322,323,324,325],"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 Stage IIIA","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":328,"type":40},"2026-03-04",{"date":330,"type":40},"2024-08-15",{"date":332,"type":19},"2027-12",{"name":334,"class":47},"University of California, Davis",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":20,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"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":177,"type":19},[107],"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",[27,29,30,345],"Carcinoma, Breast",[347,348,349,350],"breast","cancer","HER2","carcinoma","2026-02-27",{"date":353,"type":40},"2026-03-03",{"date":355,"type":40},"2024-10-01",{"date":357,"type":19},"2028-10",{"name":359,"class":47},"George Washington University",{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":20,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"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":368,"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.",[372,373,374,375,27,29,30,376,69,377,378,379],"Breast Cancer, Stage 0","Colorectal Cancer Stage I","Head and Neck Cancer Stage I","Lymphoma","Colorectal Cancer Stage II","Head and Neck Cancer Stage II","Head and Neck Cancer Stage III","Lymphoproliferative Disorders","2026-02-23",{"date":382,"type":40},"2026-02-25",{"date":384,"type":40},"2023-07-07",{"date":386,"type":19},"2026-11-30",{"name":119,"class":47},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":20,"phases":398,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":96},"100607414","phase-2-neoadjuvant-sbrt-with-intratumoural-pembrolizumab-followed-by-neoadjuvant-chemotherapy-in-breast-cancer-100607414","NCT07188246","Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer","A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer","BRINK","Inclusion Criteria:\n\n1. Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes.\n2. Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers.\n\n   a. Clinical staging based on AJCC 8th edition.\n3. Lesion palpable by treating physician.\n4. Plan to be treated with neoadjuvant chemotherapy.\n5. Able to tolerate core needle biopsies and pembrolizumab injection.\n6. 18 years of age or older.\n7. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc).\n2. Prior treatment for current breast cancer.\n3. Previous radiation therapy to the same breast.\n4. Inflammatory breast carcinoma.\n5. Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes.\n6. Recurrent breast cancer.\n7. Clinical or radiologic evidence or suspicion of distant metastatic disease (metastatic workup that requires additional imaging to follow-up on suspicious findings will exclude patients).\n8. Any collagen vascular disease precluding radiotherapy at the discretion of the treating radiation oncologist (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis).\n9. No prior stem cell transplantation.\n10. Any poorly controlled autoimmune conditions.\n11. Current use of corticosteroids or immunosuppressants.\n12. Any other malignancy at any site (except non-melanomatous skin cancer) \\\u003C5 years prior to study enrollment. Synchronous bilateral breast cancers are acceptable.\n13. Inability to tolerate core needle biopsies or pembrolizumab injection.\n14. Pregnant or lactating.\n15. Under 18 years of age.\n16. Inability or unwillingness to provide informed consent.\n17. Inability or unwillingness to complete study assessments\u002Finterventions and follow-up assessments.",{"count":397,"type":19},40,[107],"This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy. The investigators aim to augment this effect with the addition of pembrolizumab, a monoclonal antibody that binds to and blocks programmed cell death protein 1 (PD-1).",[62,29,30,160,159],[270,271,402],"Breast SBRT","2026-02-09",{"date":405,"type":40},"2026-02-11",{"date":407,"type":40},"2026-01-19",{"date":409,"type":19},"2029-02",{"name":411,"class":47},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":153,"minAge":56,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":20,"phases":422,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"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":421,"type":19},130,[263],"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",[27,29,30,425,426],"HR+ Breast Cancer","AI-related Musculoskeletal Pain","2025-11-24",{"date":429,"type":40},"2025-12-02",{"date":431,"type":19},"2025-12",{"date":433,"type":19},"2027-05",{"name":435,"class":47},"Gustave Roussy, Cancer Campus, Grand Paris",{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":153,"minAge":56,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":20,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":459},"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":445,"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.",[449,27,29,30],"Breast Cancer Stage 0","2025-09-02",{"date":452,"type":40},"2025-09-09",{"date":454,"type":40},"2024-03-13",{"date":456,"type":19},"2027-08-31",{"name":458,"class":47},"Weill Medical College of Cornell University",4,{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":153,"minAge":468,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":20,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":48},"100508165","radiotherapy-dose-adaptation-based-on-tumor-biology-in-patients-with-cn2b-n3-breast-cancer-100508165","NCT05896865","Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer","Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial","RADAPT-N3","Inclusion Criteria:\n\n* Female with age 19 or older\n* Metastasis to internal mammary and\u002For supraclavicular lymph nodes, assessed by radiological exams and\u002For biopsy\n* Underwent neoadjuvant chemotherapy\n* Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy\n* Eastern Cooperative Oncology Group performance status 0-2\n* Informed consent\n\nExclusion Criteria:\n\n* Previous history of radiation therapy to the chest\n* Distant metastasis","19 Years",{"count":470,"type":19},120,[22],"The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy.\n\nThe main questions it aims to answer are:\n\n* 5-year disease-free survival\n* 5-year overall survival\n* 5-year locoregional recurrence\n* Adverse events after radiation therapy\n* Quality of life\n\nParticipants will be assessed by multi-dimensional methods before and after radiotherapy:\n\n* Disease status evaluation including physical and radiological examination\n* Quality of life assessment with questionnaires (BREAST-Q)\n* Adverse event assessment according to CTCAE version 5.0",[30],"2025-06-27",{"date":476,"type":40},"2025-06-29",{"date":478,"type":40},"2023-03-16",{"date":480,"type":19},"2030-03-16",{"name":482,"class":47},"Samsung Medical Center",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":152,"sex":153,"minAge":56,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"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","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.",[27,29,30,160],[495],"TREM-1 in non metastatic HER-2 negative breast cancer","2025-04-27",{"date":498,"type":40},"2025-04-30",{"date":500,"type":19},"2025-09-15",{"date":502,"type":19},"2029-09",{"name":504,"class":47},"Rahma Esam Salama Esawi",{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":20,"phases":515,"briefSummary":516,"conditions":517,"keywords":518,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"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":514,"type":19},45,[107,263],"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.",[62,27,29,30],[519,520,521,522,523,524,525,274,526,527],"Radiation","Chemoradiation","Chemotherapy","Chemo","T-DM1","xeloda","capecitabine","Combination treatment","trastuzumab","2025-04-15",{"date":530,"type":40},"2025-04-18",{"date":532,"type":40},"2022-07-11",{"date":534,"type":19},"2029-12",{"name":536,"class":47},"University of Virginia",{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":153,"minAge":56,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":20,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":550,"leadSponsor":552,"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.",[62,29,30,27],{"date":548,"type":40},"2025-04-08",{"date":384,"type":40},{"date":551,"type":19},"2030-07-07",{"name":553,"class":47},"Covenant Health Cancer Center",{"id":555,"slug":556,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":20,"phases":562,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":4},"100578376","the-efficacy-and-safety-of-cdk46-inhibitors-in-combination-with-endocrine-therapy-in-the-neoadjuvant-treatment-100578376","NCT06810492","The Efficacy and Safety of CDK4\u002F6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment","A Single-arm Exploratory Study of the Efficacy and Safety of CDK4\u002F6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+\u002FHER2- Early Breast Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and\u002For multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and\u002For PR\\>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).\n3. Patients must have histologically confirmed ER and\u002For PR \\>10%, HER2-, early invasive breast cancer.\n4. Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD\u002FSD, advanced age, and inability to tolerate chemotherapy with underlying diseases.\n5. ECOG PS score 0-2.\n6. Patients must be able and willing to swallow and retain oral medications.\n7. Premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test.\n8. Patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy.\n9. Absolute neutrophil count ≥ 1500\u002FµL, platelet ≥ 100000\u002Fmm3, hemoglobin ≥ 10g\u002FdL\n\nExclusion Criteria:\n\n1. Prior treatment with any CDK inhibitor.\n2. Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.\n3. History of anaphylaxis caused by chemical or biologic components similar to dalsily.\n4. Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.\n5. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n6. Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission.\n7. Patients with any history of malignancy are not eligible.\n8. Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.",{"count":397,"type":19},[22],"To explore the efficacy and safety of CDK4\u002F6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive\u002FHER2-negative breast cancer.\n\nThis study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+\u002FHER2- breast cancer.",[30,29],[566,567,568,569],"Hormone receptor (HR) positive","HER2 negative","neoadjuvant treatment","CDK4\u002F6 inhibitors","2025-03-14",{"date":572,"type":40},"2025-03-17",{"date":574,"type":19},"2025-04-01",{"date":576,"type":19},"2027-12-01",{"name":578,"class":47},"Hongmei Zheng, PhD",{"id":580,"slug":581,"hasResults":11,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":20,"phases":589,"briefSummary":590,"conditions":591,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":96},"100440865","phase-2-correlation-of-clinical-response-to-pathologic-response-in-patients-with-early-breast-cancer-100440865","NCT05020860","Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer","A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer","RESPONSE","Inclusion Criteria:\n\n* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.\n* Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).\n\nTo be considered \"high risk,\" at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \\\u003C 6; 4) Ki-67 ≥ 30%.\n\n* Tumors must be at least 2 cm by clinical exam or ultrasound\n* Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.\n* ECOG performance status of 0 or 1\n* Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.\n* Adequate organ function, as determined by the following parameters:\n\n  * Absolute Neutrophil Count (ANC) ≥ 1200\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome\n  * Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN\n  * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN\n  * Serum creatinine ≤ institutional ULN\n* The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.\n* Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of Stage IV disease\n* Inflammatory breast cancer\n* Participants who are pregnant or lactating\n* History of an excisional biopsy or lumpectomy performed prior to study entry\n* Prior treatment with anthracyclines for any malignancy.\n* Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.\n* History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:\n\n  * Angina pectoris requiring the use of anti-anginal medication\n  * Ventricular arrhythmias except for benign premature ventricular contractions\n  * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\n  * Conduction abnormality requiring a pacemaker\n  * Valvular disease with documented compromise in cardiac function\n  * Symptomatic pericarditis\n  * Documented cardiomyopathy\n  * History of documented congestive heart failure (CHF)\n  * Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.\n* Current HIV, hepatitis B, or hepatitis C infection\n* History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.\n* Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.\n* Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.",{"count":588,"type":19},185,[107],"The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.",[62,320,592,160,29,30,593,594,595,596,597],"Breast Cancer Female","Triple Negative Breast Cancer","Hormone Receptor-positive Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Neoplasms","Estrogen Receptor-positive Breast Cancer","2025-02-25",{"date":600,"type":40},"2025-02-27",{"date":602,"type":40},"2023-04-18",{"date":604,"type":19},"2029-11",{"name":606,"class":47},"Baylor Breast Care Center",{"id":608,"slug":609,"hasResults":11,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":20,"phases":616,"briefSummary":617,"conditions":618,"keywords":623,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"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":615,"type":19},399,[263],"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).",[619,620,27,29,30,621,622],"ER+ Breast Cancer","HER2-negative Breast Cancer","Drug-Related Side Effects and Adverse Reactions","Musculoskeletal Pain",[624],"Quality of Life","2024-11-04",{"date":627,"type":40},"2024-11-05",{"date":629,"type":19},"2024-12",{"date":631,"type":19},"2028-11-30",{"name":633,"class":634},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK"]