[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1550,0,25,[9,41,70,113,134,160,178,214,243,262,285,311,332,360,385,407,429,451,460,488,507,539,559,586,607],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053422","phase-2-a-phase-ii-study-evaluating-the-efficacy-and-safety-of-inavolisib-plus-ribociclib-plus-fulvestrant-versus-placebo-plus-ribociclib-plus-fulvestrant-in-participants-with-advanced-breast-cancer-100053422",false,"NCT07405801","A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer","A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent\n* Documented estrogen receptor (ER)-positive and\u002For progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines, defined as \\>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)\n* Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen\n* Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n\nExclusion Criteria:\n\n* Metaplastic breast cancer\n* Radiotherapy within 2 weeks before randomization\n* Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible\n* Any history of leptomeningeal disease or carcinomatous meningitis","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).",[27],"Breast Cancer","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-04-07",{"date":36,"type":21},"2030-02-26",{"name":38,"class":39},"Hoffmann-La Roche","INDUSTRY",49,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100053420","to-assess-the-correlation-of-high-resolution-specimen-pet-ct-imaging-using-the-xeos-aura-10-pet-ct-with-the-histopathology-results-and-long-term-outcome-of-patients-undergoing-resective-cancer-surgery-100053420","NCT06970275","To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","PETRiS","Inclusion Criteria :\n\nAll patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT.\n\nPatients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent.\n\nExclusion Criteria:\n\n* Under the age of 18 years at the time of resective surgery.\n* Women who are pregnant or breastfeeding.",{"count":50,"type":21},850,"OBSERVATIONAL","This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.",[54,27,55,56],"Prostate Cancers","Head and Neck Cancer","Cancer",[58,59,60,61],"PET-CT","Registry","Imaging","cancer",{"date":31,"type":32},{"date":64,"type":32},"2025-11-19",{"date":66,"type":21},"2031-01-15",{"name":68,"class":39},"XEOS Medical",2,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":91,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100053405","phase-1-atezolizumab-plus-tivozanib-in-immunologically-cold-tumor-types-100053405","NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","99 Years",{"count":78,"type":21},29,[80,24],"PHASE1","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[83,84,27,85,86,87,88,89,90],"Bile Duct Cancer","Gall Bladder Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[92,93,94,95,96,97,98,99,100,101,102,103],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor",{"date":31,"type":32},{"date":106,"type":32},"2021-12-07",{"date":108,"type":21},"2027-06",{"name":110,"class":111},"University of Florida","OTHER",1,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100053586","phase-1-a-study-to-evaluate-the-effect-of-gdc-4198-alone-and-in-combination-with-giredestrant-versus-abemaciclib-and-giredestrant-in-participants-with-locally-advanced-or-metastatic-estrogen-receptor-positive-er-human-epidermal-growth-factor-receptor-negative-her2--breast-cancer-100053586","NCT07100106","A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer","A Phase Ib\u002FII Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4\u002F6 Inhibitor","MoonROSE","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.\n* Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO\u002FCAP or ESMO guidelines.\n* Disease progression during or after treatment with an approved cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor and approved endocrine therapy (ET) in the locally advanced or metastatic setting.\n* Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy \\>= 6 months.\n\nExclusion Criteria:\n\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines.\n* Have received more than one-line of therapy for locally advanced or metastatic disease.\n* Have received prior chemotherapy for metastatic breast cancer.\n* Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4\u002F6 inhibitor within 21 days prior to initiation of study drug.\n* Malabsorption condition or other gastrointestinal (GI) conditions\u002Fsurgeries that the investigator assesses may significantly interfere with enteral absorption\n* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.\n* Known allergy or hypersensitivity to any component of the study treatments.",{"count":122,"type":21},285,[80,24],"The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.",[27],{"date":31,"type":32},{"date":128,"type":32},"2025-10-07",{"date":130,"type":21},"2028-08-31",{"name":132,"class":39},"Genentech, Inc.",52,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":142,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":112},"100053386","a-cohort-study-of-combined-cryoablation-and-thermal-ablation-for-non-surgical-treatment-of-breast-cancer-patients-100053386","NCT07238894","A Cohort Study of Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients","Peking University People's Hospital Breast Surgery Department","Inclusion Criteria:\n\n* 1\\) Aged 18 or above; 2) Breast cancer confirmed by core needle biopsy; 3) Tumor lesions clearly visible on ultrasound; 4) No contraindications for cryoablation such as coagulation disorders; 5) Presence of reasons unsuitable for conventional surgical resection: patient's condition cannot tolerate general anesthesia or surgical treatment; due to unresectable and\u002For metastatic disease; patient refuses surgery, etc.; 6) Agree to undergo ablation surgery and sign the consent form.\n\nExclusion Criteria:\n\n* 1\\) Missing clinical and pathological data (such as imaging and pathological materials); 2) Pregnant or lactating women; 3) Known allergies, intolerances, or contraindications to cryotherapy (such as cryoglobulinemia, presence of implanted electronic devices); 4) Vulnerable populations, including those with neurological disorders, cognitive impairments, critically ill patients, etc.",true,"FEMALE","80 Years",{"count":145,"type":21},200,[147],"NA","Although surgical resection is the gold standard for early breast cancer treatment, some patients cannot tolerate surgery due to medical conditions or refuse surgical treatment for cosmetic reasons. In recent years, the rapid development of ablation technology has provided new directions for breast cancer patients who are not suitable for surgical treatment. Ablation uses high or low temperatures to deactivate lesions or tissues, which are gradually absorbed by the body, achieving local treatment purposes. Its safety and efficacy have been preliminarily confirmed. As an advanced minimally invasive medical device independently developed in China, the combined cryo-thermal ablation system treats tumors using a combined mode of deep cryogenic freezing and high-intensity heating. It has been approved for ablation treatment of various solid tumors including lung cancer, pancreatic cancer, kidney cancer, prostate cancer, breast cancer, bone and soft tissue sarcomas.\n\nThis project proposes a prospective cohort design, based on the breast disease cohort database of Peking University People's Hospital Breast Center. It will enroll patients pathologically diagnosed with breast cancer, determined unsuitable for surgical treatment, and have received combined cryo-thermal ablation. The registered data will be used to evaluate the effectiveness and safety of percutaneous ultrasound-guided cryo-thermal composite ablation in this population.",[150,27],"Ablation",[152],"Combined Cryoablation and Thermal Ablation",{"date":31,"type":32},{"date":155,"type":32},"2026-03-03",{"date":157,"type":21},"2028-10-01",{"name":159,"class":111},"Peking University People's Hospital",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":112},"100053252","phase-2-an-open-label-bayesian-adaptive-phase-ii-clinical-study-in-hrher2--advanced-breast-cancer-after-progression-on-standard-therapy-100053252","NCT07117630","An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+\u002FHER2- Advanced Breast Cancer After Progression on Standard Therapy","Inclusion Criteria:\n\n* Women aged ≥ 18 years old.\n* Patients with histologically confirmed HR+\u002FHER2- invasive breast cancer (specific definition: ER \\> 10% tumor cell positivity by immunohistochemistry is defined as ER positive, PR positive, PR \\> 10% tumor cell positivity is defined as PR positive; HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification is defined as HER2 negative).\n* Patients with HR+\u002FHER2- advanced breast cancer who have experienced disease progression after receiving systemic therapy including CDK4\u002F6 inhibitors and endocrine therapy.\n* Patients whom the investigator judges to be suitable for continued endocrine therapy\n* Patients with at least one measurable lesion per RECIST version 1.1 criteria (≥ 20 mm on conventional CT scan, ≥ 10 mm on spiral CT scan, and without prior radiotherapy for measurable lesion).\n* Patients whose main organs function normally by meeting the following requirements:\n* Hematology criteria: HB ≥ 90 g\u002FL (no blood transfusion within 14 days); ANC ≥ 1.5 × 109\u002FL; PLT ≥ 75 × 109\u002FL;\n* Blood chemistry criteria: TBIL ≤ 1.5 × ULN (upper limit of normal); ALT and AST ≤ 3 × ULN; if liver metastasis is present, then ALT and AST ≤ 5 × ULN; serum Cr ≤ 1× ULN, endogenous creatinine clearance \\> 50 mL\u002Fmin (Cockcroft-Gault formula);\n* Patients who have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks prior to the start of the study and have recovered from acute toxicities of prior therapies (if a surgery has been undergone, the wound has completely healed); patients who have no peripheral neuropathy or Grade I peripheral neurotoxicity;\n* Patients with ECOG score ≤ 2, and life expectancy ≥ 3 months;\n* Female subjects of childbearing potential are required to use a medically acceptable method of contraception during study treatment and for at least 3 months after the last dose of study drug;\n* Subjects will be enrolled in this study voluntarily, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients who have received radiotherapy (except for palliative reasons), chemotherapy, immunotherapy, or bisphosphonates (except for bone metastases) within 3 weeks prior to treatment.\n* Patients with uncontrolled central nervous system metastases (defined as symptomatic or requiring the use of corticosteroids or mannitol to control symptoms).\n* Patients with a history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmia.\n* Patients with ongoing ARs ≥ Grade 1 due to prior therapy. Exception to this is alopecia or those that, in the opinion of the investigator, should not be excluded. Such cases should be clearly documented in the investigator's notes.\n* Patients who have undergone major surgery (except for minor outpatient surgery, such as placement of vascular access) within 3 weeks of the first course of study treatment.\n* Pregnant or lactating patients.\n* Patients with a history of malignancy (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past five years.\n* Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors affecting the taking and absorption of drugs.\n* Presence of a third space effusion (such as large pleural fluid and ascites) that cannot be controlled by drainage or other methods.\n* Long-term unhealed wounds or incompletely healed fractures.\n* Patients with known HBV or HCV infection active phase or hepatitis B DNA ≥ 500, or chronic phase with abnormal liver function.\n* Those with allergies, or those who are known to have a history of allergy to the drug components of this study.\n* For the Experimental: PARP inhibitor + Fulvestrant + Pioglitazone arm , patients with pathogenic germline BRCA1\u002F2 mutations.",{"count":167,"type":21},60,[24],"This is a prospective, Phase II, open-label, two-arm parallel study evaluating the efficacy and safety of combined treatment (L-Ornithine L-Aspartate, N-Acetylcysteine) with CDK4\u002F6 inhibitors and Fulvestrant in patients with HR-positive\u002FHER2-negative advanced breast cancer (ABC) who have progressed on prior standard therapy including CDK4\u002F6 inhibitors and endocrine therapy.",[27],{"date":31,"type":32},{"date":173,"type":32},"2025-09-25",{"date":175,"type":21},"2027-12",{"name":177,"class":111},"Fudan University",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":195,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100054097","phase-1-a-study-of-nt-175-in-adult-participants-with-advanced-malignancies-that-are-positive-for-hla-a0201-and-the-tp53-r175h-mutation-100054097","NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":186,"type":21},45,[80],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[190,191,192,87,27,193,86,194],"Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Carcinoma","Other Solid Tumors","Myeloid Neoplasms (AML\u002FMDS)",[196,197,198,199,200,201,202,27,86,203,204,205],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR",{"date":31,"type":32},{"date":208,"type":32},"2023-07-12",{"date":210,"type":21},"2029-07-31",{"name":212,"class":39},"AstraZeneca",18,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":224,"conditions":225,"keywords":229,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":112},"100054018","collection-of-csf-samples-from-participants-with-metastatic-triple-negative-breast-cancer-tnbc-and-her2-breast-cancer-with-no-prior-history-nor-active-radiographically-detectable-brain-metastases-100054018","NCT07619534","Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases","Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer","* INCLUSION CRITERIA:\n* Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease.\n* Participants must be able to undergo lumbar puncture (LP) and brain MRI.\n* Women age \\>= 18 years\n* Adequate organ function as defined below:\n\n  * Creatinine \\\u003C=1.5 x institutional upper limit of normal (ULN)\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n\\- Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior history or current MRI-detected brain metastasis or leptomeningeal disease\n* Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies.\n* Pregnancy","120 Years",{"count":223,"type":21},139,"Background:\n\nBreast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research.\n\nObjective:\n\nTo collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body.\n\nEligibility:\n\nPeople aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain.\n\nDesign:\n\nParticipants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain.\n\nParticipants will come to the NIH clinic to have their samples collected:\n\n* Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure.\n* Blood.\n* Saliva or cheek swabs. They will rub a cotton swab inside of their mouth.\n* Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study.\n\nParticipants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples....",[27,226,227,228],"Breast Carcinoma","Cancer of the Breast","Malignant Neoplasm of Breast",[230,231,232,233],"Triple Negative Breast Cancer (TNBC)","HER2-Postitive","Metastatic Breast Cancer","Cerebral Spinal Fluid Collection","NOT_YET_RECRUITING",{"date":31,"type":32},{"date":237,"type":21},"2026-07-16",{"date":239,"type":21},"2034-07-01",{"name":241,"class":242},"National Cancer Institute (NCI)","NIH",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":112},"100053622","phase-3-effects-metabolic-mechanisms-and-predictors-of-response-to-acupuncture-in-treating-psychoneurological-symptoms-among-breast-cancer-survivors-100053622","NCT07695948","Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer Survivors","Inclusion Criteria:\n\n* ≥ 18 years of age\n* With histologically confirmed Stage 0-III ER\u002FPR-positive HER2-negative breast cancer\n* Currently receiving adjuvant endocrine therapy\n* Completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior to recruitment\n* Acupuncture-naïve\n* Have self- reported pain, fatigue, and sleep disturbance in the last month with an average severity rating ≥ 3 (0-10 numeric rating scale) for at least 2 of the 3 symptoms.\n\nExclusion Criteria:\n\n* Taking methylsulfonylmethane or glutathione supplements\n* Physically or cognitively unable to complete the study procedures\n* Pregnant",{"count":250,"type":21},252,[252],"PHASE3","The purpose of this study is to examine the effect, mediators and predictors of treatment response of acupuncture in treating the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) among breast cancer survivors.",[27],{"date":31,"type":32},{"date":257,"type":21},"2026-09-01",{"date":259,"type":21},"2031-08-31",{"name":261,"class":111},"University of Illinois at Chicago",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":112},"100053738","real-world-evaluation-of-patient-outcomes-and-experiences-with-ribociclib-early-adopters-100053738","NCT07243002","Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.","Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters: A Hybrid Study With Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review.","REPOWER","Inclusion Criteria:\n\n* Males or females.\n* Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx\u002FICD-10-CMC50.xx).\n* Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis.\n* Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria.\n* Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment).\n* Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date:\n\n  * Tested positive for estrogen receptor (ER+), or\n  * Tested positive for progesterone receptor (PR+), or\n  * Tested positive for both.\n* Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date.\n\nExclusion Criteria:\n\n* Patients with local or distant breast cancer recurrence before the ribociclib\u002Fabemaciclib initiation date.\n* Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local\u002Fregional, metastatic) during the 12-month baseline period.\n* Patients physically\u002Fmentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.",{"count":271,"type":21},3000,"This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life \\[HRQoL\\], work productivity, and etc.), among HR+\u002FHER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+\u002FHER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.",[27],[275,27,276],"ribociclib, abemacicblib","Non interventional study","2026-07-09",{"date":31,"type":32},{"date":280,"type":32},"2025-12-15",{"date":282,"type":21},"2030-04-30",{"name":284,"class":39},"Novartis Pharmaceuticals",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":292,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":112},"100053279","a-study-of-mental-health-care-in-people-with-cancer-100053279","NCT06037954","A Study of Mental Health Care in People With Cancer","Mental Health Care Initiation Intervention for Older Adults With Cancer","Inclusion Criteria:\n\nPatients\n\n* Per medical record and\u002For self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older\n* Per medical record and\u002For self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment\n* Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9)\n* Per self-report, fluent in English\\*\\* \\*\\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:\n\n  1. How well do you speak English? (must respond \"very well\" or \"well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n  2. What is your preferred language for healthcare? (must respond English)\n\nProviders\n\n* Per self-report, works in oncology, nursing, social work, psychology, or psychiatry\n* Per self-report, currently works in oncology at least 50% of the time\n* Per self-report, provided cancer care for at least three years at time of consent\n* Per self-report, fluent in English\n\nExclusion Criteria:\n\nPatients\n\n* Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11\n* Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures\n* Per medical record and\u002For self-report, receiving hospice care at the time of enrollment\n* Per medical record and\u002For self-report, currently enrolled in mental health treatment\n\nProviders\n\n* N\u002FA","65 Years",{"count":294,"type":21},130,[147],"The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.",[27,298,299,90],"Colorectal Cancer","Lung Cancer",[301,302,303],"65 years and older","Mental health care","23-218",{"date":31,"type":32},{"date":306,"type":32},"2023-09-07",{"date":308,"type":21},"2026-09",{"name":310,"class":111},"Memorial Sloan Kettering Cancer Center",{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":112},"100054088","early-intervention-100054088","NCT05326165","Early Intervention","Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study","Inclusion Criteria:\n\n* Eligible participants will be female, \\>\u002F= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included.\n* Eligible participants will demonstrate low volume swelling (RVC 5-\\\u003C10%) \\>\u002F=12 weeks postoperatively\n* Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document.\n* Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and\u002For regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC.\n\nExclusion Criteria:\n\n* Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation.\n* Participants will not be eligible if they have been diagnosed and\u002For treated for BCRL.\n* Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded.\n* Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.",{"count":319,"type":21},40,[147],"This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.",[27,323],"Breast Cancer Treatment Related Lymphedema",[27,323],{"date":31,"type":32},{"date":327,"type":21},"2027-05",{"date":329,"type":21},"2027-06-30",{"name":331,"class":111},"Massachusetts General Hospital",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":142,"minAge":18,"maxAge":143,"enrollmentInfo":339,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":341,"conditions":342,"keywords":353,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":112},"100053937","screening-for-bcrl-in-targeted-therapy-for-breast-cancer-100053937","NCT05142800","Screening For BCRL In Targeted Therapy For Breast Cancer","Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer","Inclusion Criteria:\n\n* Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF\u002FHCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.\n* Subjects that will be eligible for the study include:\n* Females between 18 and 80 years of age\n* With a history of breast cancer\n* 4 weeks or more post-surgery\n* With or without edema\n* Undergoing treatment with targeted therapy for early or metastatic disease.\n\nExclusion Criteria:\n\n\\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).",{"count":340,"type":21},261,"This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.\n\nA Perometer and Sozo devise will be used to measure volume changes",[343,344,345,346,347,348,349,350,351,352,27],"Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema of the Hands","Edema","Edema Arm","Breast Cancer Lymphedema","Breast Cancer Metastatic","Breast Cancer Stage",[343,344,345,346,347,348,349,350,351,352,27],{"date":31,"type":32},{"date":356,"type":32},"2018-12-13",{"date":358,"type":21},"2026-09-30",{"name":331,"class":111},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":112},"100053502","phase-1-study-of-autologous-car-t-cells-targeting-b7-h3-in-tnbc-ic9-carb7-h3-t-cells-100053502","NCT06347068","Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells","Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60% (see APPENDIX VI- Karnofsky Scale))\n4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)\n\n   1. ER- and PR-negative: defined as \\\u003C 1% staining by immunohistochemistry (IHC)\n   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \\\u003C 2.0\n\nExclusion Criteria:\n\n1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.\n2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1",{"count":368,"type":21},42,[80],"This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed\u002Frefractory triple-negative breast cancer (TNBC).",[27,372,373,374],"Relapse","Resistant Cancer","Triple Negative Breast Cancer",[376,377],"cellular therapy","biologic therapy",{"date":31,"type":32},{"date":380,"type":32},"2024-06-27",{"date":382,"type":21},"2030-05",{"name":384,"class":111},"UNC Lineberger Comprehensive Cancer Center",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":406},"100053751","phase-1-clinical-trial-of-tqb3126-for-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-in-breast-cancer-subjects-100053751","NCT07697443","Clinical Trial of TQB3126 for Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Breast Cancer Subjects","Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3126 in Subjects With Breast Cancer","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good treatment compliance.\n2. Aged 18 to 75 years at the time of informed consent signature; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; estimated survival expectancy of more than 3 months.\n3. Histopathologically confirmed breast cancer.\n4. Documented disease progression confirmed by clinical or imaging evidence during or after the most recent prior systemic therapy prior to the first study drug administration.\n5. Have evaluable lesions per RECIST v1.1 criteria (measurable lesions; or bone-only metastases with at least one osteolytic or mixed lesion).\n6. Adequate tissue samples shall be provided at screening for gene mutation testing to clarify genetic status.\n7. Laboratory test results meet the criteria specified in the protocol (blood routine, liver and renal function, coagulation function, cardiac ultrasound Left Ventricular Ejection Fraction(LVEF) and other indicators are all within the protocol-specified ranges).\n8. Subjects of childbearing potential must agree to use effective contraceptive measures throughout the study and for 6 months after study completion (the same requirement applies to male subjects); serum or urine pregnancy test result is negative within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Other malignant tumors within 5 years prior to first dose, except those cured by single surgical treatment with at least 5 years of disease-free survival, or cured differentiated thyroid cancer, cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors.\n2. Conditions affecting intravenous access or blood sampling, or multiple factors affecting oral drug administration\u002Fabsorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction).\n3. Unresolved toxicity from prior therapy of Grade \\>1 (CTCAE v6.0), except Grade 2 alopecia, Grade 2 anemia, clinically insignificant laboratory abnormalities, or hypothyroidism stable on hormone replacement therapy.\n4. Major surgery, significant traumatic injury within 4 weeks before first dose, anticipated need for major surgery during the study, or long-standing unhealed fracture.\n5. Any bleeding event of Grade \\>=3 within 4 weeks before first dose.\n6. Arterial\u002Fvenous thrombotic events within 6 months before first dose (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism), excluding catheter-related or superficial venous thrombosis.\n7. Active viral hepatitis that is poorly controlled (Hepatitis B Virus (HBV)\u002FHepatitis C Virus (HCV)-infected subjects meeting protocol-specified criteria may be enrolled).\n8. Active syphilis infection requiring treatment.\n9. Active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or radiation pneumonitis requiring treatment, or history of\u002Fcurrent interstitial lung disease (ILD).\n10. History of psychotropic substance abuse unable to be discontinued, mental disorders, epilepsy requiring treatment, or severe psychiatric\u002Fneurological disease.\n11. Planned or prior allogeneic bone marrow or solid organ transplantation.\n12. Decompensated cirrhosis (Child-Pugh Class B or C) or history of hepatic encephalopathy.\n13. Significant cardiovascular disease, including New York Heart Association(NYHA) Class \\>II heart failure, clinically significant ventricular arrhythmia, unstable angina, myocardial infarction within 12 months, markedly prolonged QT interval corrected by Fridericia's formula (QTcF), or personal\u002Ffamily history of congenital long QT syndrome.\n14. Poorly controlled hypertension (resting systolic BP \\>=160 mmHg or diastolic BP \\>=100 mmHg on at least 2 measurements \\>=24 hours apart).\n15. Active or uncontrolled serious infection (Grade \\>=2).\n16. Renal failure requiring hemodialysis or peritoneal dialysis; or history of\u002Fcurrent nephrotic syndrome (except cured) or chronic nephritis.\n17. History of immunodeficiency, including HIV infection or other acquired\u002Fcongenital immunodeficiency diseases.\n18. Poorly controlled autoimmune disease requiring immunosuppressants or systemic corticosteroids for immunosuppression, continued within 7 days before first dose (except low-dose corticosteroids).\n19. Clinically significant endometrial abnormalities (including hyperplasia, dysfunctional uterine bleeding, etc.).\n20. Tumor-related conditions\u002Ftreatments: anti-cancer therapy within 3 weeks before first dose or still within the drug's washout period; prior local radiotherapy not meeting protocol-specified interval or target lesion requirements; use of National Medical Products Administration (NMPA)-approved proprietary Chinese medicine with anti-tumor indications within 1 week before first dose; imaging showing tumor invasion of major vessels with risk of fatal hemorrhage; uncontrolled pleural effusion\u002Fascites\u002Fmoderate-or-greater pericardial effusion requiring repeated drainage; known leptomeningeal metastasis or uncontrolled brain metastasis symptoms; severe skeletal-related events due to bone metastases.\n21. Known hypersensitivity to the study drug or its excipients.\n22. Participation in and use of another investigational anti-tumor drug within 4 weeks before first dose.\n23. Any concomitant disease or condition that, in the investigator's judgment, seriously endangers subject safety or study compliance, or any other reason making the subject unsuitable for enrollment.","75 Years",{"count":394,"type":21},306,[80,24],"The trial comprises Phase I dose escalation\u002Fexpansion and Phase II combination therapy. Using a multicenter, open-label, non-randomized design, breast cancer patients will receive TQB3126 to assess its safety, tolerability, pharmacokinetics and preliminary efficacy.",[27],"2026-07-07",{"date":31,"type":32},{"date":401,"type":21},"2026-08",{"date":403,"type":21},"2030-08",{"name":405,"class":39},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",6,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":142,"minAge":415,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":112},"100053863","a-pilot-study-assessing-myokines-during-an-exercise-regimen-after-treatment-for-breast-cancer-100053863","NCT07698314","A Pilot Study Assessing Myokines During an EXErcise Regimen After Treatment for Breast Cancer","Myo-EXERTBC: A Pilot Study Assessing Myokines During an EXErcise Regimen After Treatment for Breast Cancer","Myo-EXERTBC","Inclusion Criteria:\n\n1. Age 20-89 years\n2. Women prescribed exercise as a SOC\n3. Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast\n4. Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.\n5. Women with \\> 3 months of resistance training experience under expert guidance at the Allegheny Health Network Exercise Oncology Center\n\nExclusion Criteria:\n\n1. Any current treatment with cytotoxic chemotherapy for breast cancer\n2. Inability to safely engage in group sessions of resistance training as deemed by study PI\n3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training\n4. Pregnant women\n5. Males","20 Years","89 Years",{"count":418,"type":21},21,[147],"In this pilot study, the investigators will assess the changes in myokine production based on several different exercise regimens.",[56,27],{"date":31,"type":32},{"date":424,"type":21},"2026-06",{"date":426,"type":21},"2028-06",{"name":428,"class":111},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":141,"sex":142,"minAge":415,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100644821","instagram-and-podcast-intervention-for-breast-cancer-awareness-and-screening-100644821","NCT07673588","Instagram and Podcast Intervention for Breast Cancer Awareness and Screening","The Effect of an Instagram- and Podcast-Based Intervention on Women's Breast Cancer Awareness, Health Beliefs, and Screening Behaviors: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged 20-39 years\n* Able to read and write Turkish\n* Turkish citizens\n* Have an active Instagram account and access it at least once daily\n* No previous diagnosis of cancer\n* Willing to participate and provide informed consent\n\nExclusion Criteria:\n\n* No access to a smartphone with the Instagram application\n* Visual, hearing, or cognitive impairment that may prevent participation in the intervention\n\nWithdrawal Criteria:\n\n* Failure to complete the assigned podcast sessions during the intervention period\n* Participant request to withdraw from the study at any time","39 Years",{"count":438,"type":21},180,[147],"Breast cancer is the most common cancer among women worldwide. This randomized controlled trial aims to evaluate the effect of an Instagram- and podcast-based intervention on women's breast cancer awareness, health beliefs, and breast cancer screening behaviors among women aged 20-39 years.",[27,442],"Breast Cancer Screening","2026-07-01",{"date":445,"type":32},"2026-07-02",{"date":443,"type":21},{"date":448,"type":21},"2026-12-01",{"name":450,"class":111},"Ankara University",{"id":452,"slug":4,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":221,"enrollmentInfo":453,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":224,"conditions":454,"keywords":455,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":458,"leadSponsor":459,"locationsCount":112},"100638410",{"count":223,"type":21},[27,226,227,228],[230,231,232,233],{"date":445,"type":32},{"date":398,"type":21},{"date":239,"type":21},{"name":241,"class":242},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":487},"100625767","cardiovascular-health-education-via-virtual-reality-for-breast-cancer-survivors-receiving-anthracyclines-or-trastuzumab-100625767","NCT07426913","Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab","Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2","Inclusion Criteria:\n\n* 18 years of age or older\n* Able to speak and read in English\n* Actively receiving Trastuzumab or an anthracycline-based treatment\n* Currently receiving immunotherapy. This includes pembrolizumab and atezolizumab.\n* Diagnosed with stages 0-III Breast Cancer\n\nExclusion Criteria:\n\n\\- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)",{"count":468,"type":21},30,[147],"The main goal of this study is to test a virtual reality (VR) program, Survivors' Virtual Reality Survivorship Experience (SurviVRSE), designed to help Breast Cancer survivors (n=30) learn about heart health. The aims are to test the usability, feasibility, and acceptability o the intervention. Additionally, follow-up assessments will examine changes in women's cancer therapy related cardiac dysfunction knowledge and heart healthy behaviors (e.g., physical activity).",[27,472,473,474],"Anthracycline Related Cardiotoxicity in Breast Cancer","Virtual Reality","Trastuzumab",[476,93,477,478,479,480],"virtual reality","antracyclines","trastuzumab","VCU","Virginia Commonwealth University",{"date":445,"type":32},{"date":483,"type":32},"2026-05-20",{"date":485,"type":21},"2027-02-28",{"name":480,"class":111},3,{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":22,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":506},"100609444","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-gdc-0587-as-a-monotherapy-and-in-combination-with-giredestrant-in-participants-with-locally-advanced-or-metastatic-estrogen-receptor-positive-and-human-epidermal-growth-factor-receptor-2-negative-erher2--breast-cancer-100609444","NCT07214662","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+\u002FHER2-) Breast Cancer","A Phase Ia\u002FIb Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Patients With Locally Advanced Or Metastatic ER-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After CDK4\u002F6 Inhibitor Therapy","Inclusion Criteria:\n\n* Agreement to adhere to the contraception requirements\n* For females of childbearing potential ≤60 years of age and males: treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Cycle 1, Day 1 and agreement to continue LHRH agonist therapy for the duration of the study\n* Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic\n* Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO\u002FCAP or ESMO guidelines\n* Disease progression during or following treatment with an approved CDK 4\u002F6 inhibitor, with or without endocrine therapy, in the locally advanced or metastatic setting\n* Measurable, or non-measurable but evaluable, disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy ≥6 months\n* Creatinine clearance ≥60 milliliter per minute (mL\u002Fmin) (calculated through use of the Cockcroft-Gault formula)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines\n* Five or more prior lines of systemic therapy in the locally advanced or metastatic setting\n* Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study drug\n* Treatment with an approved oral endocrine therapy within 7 days prior to initiation of study drug or treatment with fulvestrant or an approved\u002Finvestigational CDK inhibitor within 21 days prior to initiation of study drug\n* History of Grade ≥3 adverse event attributed to prior CDK inhibitor therapy that resulted in permanent discontinuation of prior CDK inhibitor therapy\n* Poor peripheral venous access\n* Malabsorption condition or other gastrointestinal (GI) conditions\u002Fsurgeries that the investigator assesses may significantly interfere with enteral absorption\n* Major surgical procedure within 28 days prior to initiation of study drug\n* Untreated, active CNS metastases\n* Infection requiring systemic (i.e., oral, IV, or intramuscular) antibiotics, chronic infection requiring treatment within 1 year prior to screening, or any evidence of current infection\n* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study\n* Known history of a clinically significant abnormal ECG",{"count":496,"type":21},136,[80],"This is a first-in-human, Phase Ia\u002FIb, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \\[CDK4\\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+\u002FHER2-) breast cancer who have previously progressed during or after CDK 4\u002F6 inhibitor therapy.",[27],{"date":445,"type":32},{"date":502,"type":32},"2026-01-13",{"date":504,"type":21},"2030-06-01",{"name":132,"class":39},4,{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":213},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":515,"type":21},104,[147],"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[519,520,521,27,522,523,524,525,84,526,527,528,299,55,86,529,90,530,531],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Pancreatic Cancer","Rectal Cancer","Sarcoma",{"date":445,"type":32},{"date":534,"type":32},"2026-02-11",{"date":536,"type":21},"2027-08-31",{"name":538,"class":111},"Alliance for Clinical Trials in Oncology",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":558},"100576853","phase-3-a-study-evaluating-the-efficacy-and-safety-of-inavolisib-plus-cdk46-inhibitor-and-letrozole-vs-placebo--cdk46i-and-letrozole-in-participants-with-endocrine-sensitive-pik3ca-mutated-hormone-receptor-positive-her2-negative-advanced-breast-cancer-100576853","NCT06790693","A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4\u002F6 Inhibitor and Letrozole vs Placebo + CDK4\u002F6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4\u002F6 Inhibitor and Letrozole Versus Placebo Plus a CDK4\u002F6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","INAVO123","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast\n* Documented ER-positive and\u002For progesterone receptor-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Documented HER2-negative tumor according to ASCO\u002FCAP guidelines\n* De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant\u002Fadjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment\n* Participants who have bilateral breast cancers which are both HR-positive and HER2-negative\n* Confirmation of biomarker eligibility\n* Consent to provide fresh or archival tumor tissue specimen\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Metaplastic breast cancer\n* Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease\n* History of or active inflammatory bowel disease\n* Any active bowel inflammation\n* Prior hematopoietic stem cell or bone marrow transplantation\n* Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment",{"count":548,"type":21},450,[252],"This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4\u002F6i) and letrozole versus placebo plus a CDK4\u002F6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).",[27],{"date":445,"type":32},{"date":554,"type":32},"2025-04-09",{"date":556,"type":21},"2032-05-30",{"name":38,"class":39},232,{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":585},"100573587","phase-3-e-mindfulness-approaches-for-living-after-breast-cancer-100573587","NCT06748222","E-Mindfulness Approaches for Living After Breast Cancer","Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC","HEAL-ABC","Inclusion Criteria:\n\n* The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.\n* The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.\n* The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.\n* The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).\n* Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4\u002F6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)\n* Participant must be able to understand, speak, read, and write in English or Spanish.\n* Participant must be willing to participate in a 6-week program to receive training in mindfulness.\n* Participant must be able to use a smartphone, tablet, or other digital device.\n* Sex assigned at birth must be female.\n\nExclusion Criteria:\n\n* Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .\n* Any history or current evidence of recurrent or metastatic breast cancer.\n* Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.\n* Currently pregnant or planning to become pregnant in the near future.\n* Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.","50 Years",{"count":569,"type":21},402,[252],"NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and\u002For chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.",[27,573],"Depression",[27,575,576,577],"Mindfulness","Meditation","Digital",{"date":445,"type":32},{"date":580,"type":32},"2025-06-27",{"date":582,"type":21},"2030-02-28",{"name":584,"class":111},"NRG Oncology",364,{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":142,"minAge":18,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":597,"briefSummary":598,"conditions":599,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":606},"100506864","phase-3-evaluating-the-addition-of-adjuvant-chemotherapy-to-ovarian-function-suppression-plus-endocrine-therapy-in-premenopausal-patients-with-pn0-1-er-positiveher2-negative-breast-cancer-and-an-oncotype-recurrence-score-less-than-or-equal-to-25-100506864","NCT05879926","Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive\u002FHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25","A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive\u002FHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)","OFSET","Inclusion Criteria:\n\n* A patient cannot be considered eligible for this study unless ALL of the following conditions are met.\n\n  * The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information.\n  * Female patients must be greater than or equal to 18 years of age.\n  * Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as:\n  * Age 50 years or under with spontaneous menses within 12 months; or\n  * Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or\n  * Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or\n  * Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range.\n  * The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%).\n  * Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n  * Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n  * Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.\n  * For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.)\n  * For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.)\n  * Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).\n  * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:\n  * By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.)\n  * By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c).\n  * Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes.\n  * Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1.\n  * Oncotype DX RS (recurrence score) requirements\\*:\n  * If node-negative:\n  * Oncotype DX RS must be RS 21-25, or\n  * Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm.\n  * If 1-3 nodes involved:\n  * Oncotype DX RS must be less than 26.\n\n    \\* Patients with a \"Low Risk\" or \"MP1\" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible.\n  * The tumor must be ER and\u002For PgR-positive (progesterone receptor) by current ASCO\u002FCAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and\u002For PgR staining by IHC will be classified as positive.\n  * The tumor must be HER2-negative by current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines based on local testing results.\n  * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.\n  * Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received.\n  * Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent.\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.\n\nExclusion Criteria:\n\n* • Definitive clinical or radiologic evidence of metastatic disease.\n\n  * pT4 (pathological state) tumors, including inflammatory breast cancer.\n  * History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and\u002For previous DCIS or LCIS are eligible.)\n  * If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer.\n  * Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator.\n\nKnown results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values:\n\n* ANC (absolute neutrophil count) less than 1200\u002Fmm3;\n* Platelet count less than 100,000\u002Fmm3;\n* Hemoglobin less than 10 g\u002FdL;\n* Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin;\n* AST(aspartate aminotransferase)(SGOT)\u002FALT (alanine transminase)(SGPT): greater than 3 × institutional ULN;\n* Renal function of GFR (glomular filtration rate) less than 30 mL\u002Fmin\u002F1.73m2.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Non-epithelial breast malignancies such as sarcoma or lymphoma.\n* Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed.\n* Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin\u002Fprogesterone IUDs).\n* Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy.\n* Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.)\n* Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.","60 Years",{"count":596,"type":21},3960,[252],"This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).",[27],{"date":445,"type":32},{"date":602,"type":32},"2023-10-18",{"date":604,"type":21},"2034-07",{"name":584,"class":111},1249,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":628},"100470927","phase-1-a-study-of-an-alternative-treatment-approach-preoperative-radiotherapy-then-mastectomy-then-immediate-reconstruction-surgery-in-people-with-t4-breast-cancer-100470927","NCT05412225","A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer","Feasibility of Preoperative Radiotherapy in T3 and T4 Breast Cancer Patients Who Are Responders to Neoadjuvant Chemotherapy to Allow for Immediate Reconstruction: a Prospective Study","Inclusion Criteria:\n\n* Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer\n* cT3-4 cN0-3 tumor\n* Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.\n* Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Prior ipsilateral breast cancer\n* Bilateral breast cancer\n* Pregnant\n* Stage IV disease at presentation\n* Stable disease or progressive disease after NAC\n* Surgically unresectable breast disease\n* BMI \\>40\n* Prior history of thoracic radiotherapy",{"count":167,"type":21},[80],"The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body.\n\nThe main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.",[27,618],"Invasive Breast Cancer",[93,620,310,621],"mastectomy","22-136",{"date":445,"type":32},{"date":624,"type":32},"2022-06-06",{"date":626,"type":21},"2027-06-06",{"name":310,"class":111},7]