[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":48},"100568211","phase-1-a-study-of-abemaciclib-and-radiation-therapy-in-people-with-metastatic-breast-cancer-100568211",false,"NCT06678269","A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer","A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Both male and female patients are allowed\n* Histologically confirmed metastatic breast cancer (mBC), current stage IV.\n* Plan for ablative radiotherapy (SBRT) to a bone metastasis.\n* Documented estrogen receptor (ER) positive and\u002For progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ER or PgR positive is ≥1% per ASCO\u002FCAP guidelines.\n* HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO\u002FCAP guidelines.\n* Any line of prior treatments (hormonal therapy and chemotherapy) is permitted including prior abemaciclib, palbociclib and ribociclib.\n* At the time of enrollment, treating physician has intent to resume abemaciclib (at any dose) following radiotherapy.\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy).\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. No prior radiotherapy to the current intended target site is permitted (ie. reirradiation is excluded from this study).\n* The patient must be able to swallow oral medications.\n* The patient must have adequate organ function per the following criteria (as defined in Table 2):\n\nTable 2: Laboratory Value Guidance to Establish Adequate Organ Function Hematologic ANC: ≥1.5 x 10\\^9\u002FL Platelets: ≥100 x 10\\^9\u002FL Hemoglobin: ≥8 g\u002FdL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n\nHepatic Total bilirubin: ≤1.5 x ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted ALT and AST: ≤3 x ULN\n\n* Patient may remain on hormonal therapy and abemaciclib before enrollment.\n* Patients must discontinue other CDK4\u002F6 inhibitor (palbociclib or ribociclib) for at least 7 days and recover from the acute effects of therapy (until the toxicity resolves to ≤Grade 1) except for residual alopecia and peripheral neuropathy.\n* Measurable or non-measurable disease is permitted as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) status of ≤2 or Karnofsky Performance Status (KPS) ≥60.\n* Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.\n* Women of childbearing potential must agree and commit to the use of a highly effective method of contraception as determined to be acceptable by the investigator, from the time of informed consent until 28 days after the last dose of the investigational product. Men must agree and commit to use a barrier method of contraception while on treatment and for 4 weeks after last dose of investigational products.\n* Patients (or their legally authorized representative) must provide written, informed consent to participate in the study and follow the study procedures\n* At the discretion of the treating radiation oncologist, radiation to a metastatic bone lesion is indicated inclusive of bone lesions in the spinal column.\n\nExclusion Criteria:\n\n* Treatment to bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study. Patients who otherwise have calvarial lesions not undergoing treatment on this protocol are eligible to enroll.\n* Patients currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug\u002Fdevice used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to the start of study intervention, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* Patients who received radiation therapy ≤14 days prior to initiation of investigational agents are excluded.\n* Patients are ineligible if they have serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Females who are pregnant or lactating.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology screening).\n* Malignant spinal cord compression (ESCC2 or above)\n* Prior radiation therapy to the current target site.","ALL","18 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.",[26,27,28,29,30,31,32,33],"Metastatic Breast Cancer","Stage IV Breast Cancer","Breast Cancer","Breast Cancer Stage IV","Breast Cancer Metastatic","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Hormone-receptor-positive Breast Cancer",[26,27,28,29,30,31,32,33,35,36],"Memorial Sloan Kettering Cancer Center","24-138","RECRUITING","2026-05-26",{"date":40,"type":41},"2026-05-28","ACTUAL",{"date":43,"type":41},"2024-11-15",{"date":45,"type":20},"2028-11-30",{"name":35,"class":47},"OTHER",7,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100512964","discontinuation-of-maintenance-her-2-directed-therapy-in-long-term-survivors-of-metastatic-her-2-positive-breast-cancer-100512964","NCT05959291","Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer","Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer","Free-HER","Inclusion Criteria:\n\n1. Patients with a diagnosis of HER-2 positive metastatic (Stage IV) breast cancer.\n2. Patients in complete radiological remission (CRR), including a stable bone scan, as determined by computed tomography (CT), positron-emission tomography (PET), or PET-CT.\n\n   a. Patients with brain metastasis are allowed to participate as long as their disease has been treated and radiologically stable for at least 36 months.\n3. Patients must be on the same or current anti-HER-2 directed therapy for at least 36 months.\n4. Archived tumor biopsy available.\n5. Patients with no evidence of circulating tumor deoxyribonucleic acid (ctDNA) as determined by the Signatera assay.\n6. Patients willing to stop maintenance anti-HER-2 directed therapy with close monitoring.\n7. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score from 0 to 2.\n8. Patients ≥ 18 years of age.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients with uncontrolled metastatic disease.\n2. Patients whose disease has been controlled for less than 36 months on the same or current anti-HER-2 therapy.\n3. Patients who are currently receiving or have received treatment for a secondary cancer other than resected non-melanoma skin cancer lesions or in situ cancer within the past 24 months.\n4. Patients positive for ctDNA (which occurs when a patient's blood sample contains ≥2 target markers) with the Signatera assay.\n5. Use of investigational drugs ≤ 28 days prior to study enrollment and during the study.\n6. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the Investigator.\n7. Patients with impaired decision-making capacity.\n\nPatients who are found to be ctDNA+ at study entry will be recorded as a screen failure (Section 5.4). Their Signatera testing results will be provided to their treating physician to aid in clinical decision-making for disease management and treatment.",{"count":58,"type":20},20,[60],"NA","The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and\u002For other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission and to determine how long patients are able to stay in complete radiological remission without treatment.",[63,27],"HER2-positive Metastatic Breast Cancer","2025-08-11",{"date":66,"type":41},"2025-08-13",{"date":68,"type":41},"2023-07-17",{"date":70,"type":20},"2029-07-31",{"name":72,"class":47},"University of Miami",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":73},"100549871","phase-2-the-sappho-study-sequential-therapy-with-curative-intent-in-de-novo-her2-metastatic-breast-cancer-100549871","NCT06439693","The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer","A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study","Inclusion criteria:\n\n* Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must have stage IV breast carcinoma at diagnosis (i.e., de novo metastatic) with unequivocal evidence of metastasis on imaging.\n* Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO\u002FCAP) guidelines. HER2 status must be determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory (central testing not required). Patients with HER2 1+ or 2+ disease which is HER2 FISH positive are not eligible to enroll.\n* No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab\u002Fpertuzumab\u002Ftaxane (THP) within 6 weeks from treatment start. Prior endocrine therapy for non-invasive breast carcinoma or non-cancerous lesions is allowed if it has been completed at least 5 years prior to study entry.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, T-DM1 and tucatinib in Participants \\<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 12 weeks prior to first dose of study treatment, or within 12 weeks before starting THP for patients who start metastatic therapy prior to study entry.\n* Participants must meet the following organ and marrow function as defined below within 28 days prior to registration:\n\n  * Hgb ≥9.0 g\u002FdL\n  * Absolute Neutrophil Count ≥ 1,000 \u002Fmm3\n  * Platelets ≥100,000\u002Fmm3\n  * Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert\\'s syndrome.\n  * AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases\n  * Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL\u002Fmin\n* Participants with concurrent human immunodeficiency virus (HIV) infection are eligible provided the following criteria are met:\n\n  * CD4+ T-cell (CD4+) counts \\> 350 cells\u002FuL\n  * No history of AIDS-defining opportunistic infection within 12 months prior to enrollments\n  * Any medication used in an ART regimen must have no known interaction with the agents used in the study treatment regimen.\n* Participants with active or chronic Hepatitis B or C are eligible provided they meet the liver function criteria described in 3.1.7 and are not on a medication with a known liver function criteria described in 3.1.7 and are not on a medication with a known interaction with the agents used in the study treatment regimen. The following guidance applies:\n\n  * patients with chronic HBV infection with active disease who meet the FDA criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.\n  * patients with a history of HCV infection should have completed curative antiviral treatment. HCV viral load must be below the limit of quantification.\n  * patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.\n* Participants with brain metastases identified at diagnosis or at time of screening are eligible if the following criteria are met:\n\n  * Known, untreated brain metastases must undergo definitive local therapy - as determined by treating physician - prior to study entry.\n  * Treated brain metastases must be clinically stable since treatment. Restaging brain MRI is not required to deem eligibility if local therapy was given within 28 days from first dose of study treatment. Patients are eligible if time from local therapy and first dose of study treatment is:\n\n    * 7 days for stereotactic radiosurgery (SRS);\n    * 14 days for whole-brain radiation therapy (WBRT);\n    * 28 days for surgical resection.\n  * Patients who have already started THP prior to study entry and have brain metastasis detected at screening MRI are eligible after completion of definitive local therapy- as determined by treating physician. Systemic treatment can be interrupted as determined by the treating physician and after discussion with the Sponsor Investigator.\n* Participants with a prior or concurrent 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 (i.e., 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* This study involves agents that have known genotoxic, mutagenic and teratogenic effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her Partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of study therapy.\n* Women of childbearing potential must have had a negative pregnancy test within 14 days of registration. Childbearing potential is defined as: those who have not been surgically sterilized and\u002For have had a menstrual period in the past 12 months or who have been on ovarian suppression in the past year.\n* Ability to understand and the willingness to sign a written informed consent document indicating awareness of the investigational nature and the risks of this study\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion criteria:\n\n* Prior history of invasive breast carcinoma\n* Treatment with any other investigational agents for this condition.\n* Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery during the study.\n* Extracranial palliative radiotherapy within 7 days prior to enrollment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, trastuzumab emtansine, tucatinib.\n* Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV).\n* Subjects must not have any of the following:\n\n  * Any untreated brain lesion on screening MRI, unless approved by the Sponsor Investigator\n  * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>2 mg of dexamethasone (or equivalent).\n  * Known or concurrent leptomeningeal disease on screening MRI\n  * Poorly controlled (\\>1\u002Fweek) generalized or complex partial seizures\n* History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Sponsor-Investigator.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* History of other lung disease, such as:\n\n  * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrolment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion etc.).\n  * Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n  * Prior pneumonectomy.\n* Active or uncontrolled clinically serious infection\n* Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have ongoing ≥ Grade 2 diarrhea of any etiology\n* Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 and\u002For CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.\n* Pregnant women are excluded from this study because of potential for teratogenic or abortifacient effects of study drugs. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued prior to enrollment.",{"count":82,"type":20},72,[84],"PHASE2","The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.\n\nThe names of the study drugs involved in this study are:\n\n* Paclitaxel (a type of anti-microtubule agent)\n* Docetaxel (a type of anti-microtubule agent)\n* Nab-Paclitaxel (a type of anti-microtubule agent)\n* Trastuzumab (a type of IgG1 kappa monoclonal antibody)\n* Pertuzumab (a type of monoclonal antibody)\n* Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)\n* Tucatinib (Tyrosine Kinase HER2 Inhibitor)\n* Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)",[87,28,30,88,89,27],"Breast Cancer Female","Estrogen Receptor-positive Breast Cancer","HER2-positive Breast Cancer",[28,87,30,91,89,27],"Estrogen Receptor-Positive Breast Cancer","2025-06-23",{"date":94,"type":41},"2025-06-26",{"date":96,"type":41},"2024-08-08",{"date":98,"type":20},"2033-03-30",{"name":100,"class":47},"Dana-Farber Cancer Institute"]