[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"er-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:er-positive-breast-cancer":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,59,87,113,144,177,199,226,248,276,299,374,402],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100599536","phase-3-palazestrant-in-combination-with-ribociclib-for-the-first-line-treatment-of-erher2--advanced-breast-cancer-100599536",false,"NCT07085767","Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)","OPERA-02","Inclusion Criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).\n* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4\u002F6 inhibitors)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nExclusion Criteria:\n\n* Disease recurrence during adjuvant endocrine therapy\n* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n* History of allergic reactions to study treatment.\n* Any contraindications to letrozole and ribociclib.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.",[27,28,29,30,31],"Breast Cancer","Locally Advanced Breast Cancer","Metastatic Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma",[33,34,35,36,37,38,39,40,41,42,43,44,45],"Randomized","Multicenter","Double-Blind","Active-Controlled","Phase 3","Palazestrant","Complete Estrogen Receptor Antagonist (CERAN)","Selective Estrogen Receptor Degrader (SERD)","Ribociclib","CDK4\u002F6i","Letrozole","Aromatase inhibitors","Antineoplastic agents","RECRUITING","2026-06-12",{"date":49,"type":50},"2026-06-16","ACTUAL",{"date":52,"type":50},"2025-11-03",{"date":54,"type":21},"2032-01",{"name":56,"class":57},"Olema Pharmaceuticals, Inc.","INDUSTRY",150,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100478622","phase-3-elacestrant-for-treating-erher2--breast-cancer-patients-with-ctdna-relapse-treat-ctdna-100478622","NCT05512364","Elacestrant for Treating ER+\u002FHER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)","Elacestrant for Treating ER+\u002FHER2- Breast Cancer Patients With ctDNA Relapse","TREAT ctDNA","Inclusion Criteria:\n\n1. ctDNA screening phase:\n\n   Main inclusion criteria:\n\n   • Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR),\n\n   HER2 negative breast cancer, according to local pathologist:\n   * ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3\n   * HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH) based on single-probe average HER2 copy number, as per American Society of Clinical Oncology guidelines\n   * Intermediate to high risk of recurrence after definitive treatment for early breast cancer, defined as:\n\n   FOR PATIENTS TREATED WITH PRIMARY SURGERY:\n   * Any patient with ≥ 4 positive axillary lymph nodes (stage pN2-3).\n   * 1-3 positive axillary lymph nodes (stage pN1) and either:\n   * Tumour size ≥ 5 cm or\u002Fand\n   * Histologic grade 3 or\u002Fand\n   * Ki67≥20% or\u002Fand\n   * High genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Mammaprint high risk, Prosigna score \\>40 or EPclin risk score \\>=4.0.\n   * Negative axillary lymph nodes (stage pN0) and tumour size ≥ 2 cm and either\n   * Histologic grade 3 a or\u002Fand\n   * Ki67≥20% and\u002For\n   * High genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Mammaprint high risk, Prosigna score \\>60 or EPclin risk score \\>=4.0. FOR PATIENTS TREATED WITH NEOADJUVANT\n\n   SYSTEMIC TREATMENT FOLLOWED BY SURGERY:\n   * Patient may have received neoadjuvant endocrine therapy or neoadjuvant chemotherapy provided that:\n   * The initial tumour and\u002For the tumour after surgery meet the criteria above defined for patients treated with primary surgery or the initial tumour was staged as cT4anyN and\n   * There is no pathological complete response, defined as no invasive disease in the breast and axilla (ypT0\u002Fis ypN0).\n   * Age ≥18 years\n   * Patients must have received at least 1 year and up to 7.5 years of ET and planned to continue adjuvant ET during ctDNA screening phase\n   * Previous adjuvant CDK4\u002F6 inhibitor or PARP-inhibitor treatment is allowed provided it is completed\n   * Invasive multicentric \u002F multifocal disease is allowed provided that all the tested foci are ER+ HER2-. A sample from the highest-risk one, according to the investigator decision based on the size and grade, should be sent to Natera to build the patient ctDNA assay.\n   * Available tumour sample from resected or biopsied tissue, with a tumour content of ≥20% (30% preferred) either before or after macro dissection (if performed) and a cell viability of a minimum 100 cells.\n   * Core Needle Biopsies (CNB): recommended minimum of four (4) cores per block\n   * Fine Needle Aspirates (FNA) are not accepted\n   * The following sample types are acceptable:\n   * 6-10 unstained slides (charged and unbaked) of 10μm each (or 12-19 unstained slides at 5 μm each), PLUS one contiguous H\\&E slide. Minimum total tissue thickness must be 60μm OR\n   * FFPE tissue block with 25mm2 minimum surface area\n   * Written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\n   Main exclusion criteria:\n   * Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial\n   * Prior treatment with any SERD or investigational ER antagonist\n   * Previous history of invasive breast cancer\n   * Previous history of any other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n   * Previous history of bone marrow and\u002For organ transplant\n   * Bilateral invasive breast cancer\n   * Participation in another clinical study, with the exception of the SURVIVE study and observational (non-interventional) and non-drug intervention clinical studies. Note: patients participating in interventional studies may participate once they enter the follow-up period of the study\n   * Blood transfusion within 3 months prior to registration or during the screening.\n2. Randomised trial:\n\nMain inclusion criteria:\n\n* ctDNA positive according to the Signatera ctDNA assay (main study ctDNA test) or other ctDNA assay approved for diagnostic purposes.\n* Patients must meet the eligibility criteria for the screening phase, with the exception of the tissue sample requirements.\n* Patients must receive adjuvant ET at the time of the ctDNA positive test\n* Absence of locoregional and\u002For metastatic disease and\u002For new malignancy, as investigated by:\n* Mammogram (unilateral in case of mastectomy; not required in patients having undergone bilateral mastectomy) NOTE: if local investigator plans to use MRIs instead of mammograms during the study, MRI will have to be performed at baseline.\n* CT thorax and abdomen\u002Fpelvis with IV contrast. In case of any contra-indications (medical or regulatory): CT thorax without contrast + MRI abdomen\u002Fpelvis.\n* Technetium-99m bone scintigraphy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate organ function\n* Women of childbearing potential (WOCBP) must have a negative highly sensitive serum or urine pregnancy test within 7 days prior to randomisation.\n\nMain exclusion criteria:\n\n* Any unresolved toxic effect of prior therapies or surgical procedures of Grade ≥ 2 according to Common Terminology Criteria of Adverse Events (CTCAE) v5.0, with the exception of alopecia, peripheral neuropathy and other toxicities not considered a safety risk for the participant at investigator's discretion\n* Unable or unwilling to avoid over-the-counter medications, dietary\u002Fherbal supplements, and\u002For foods that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications\n* Any of the following cardiovascular disorders within 3 months before enrolment:\n* myocardial infarction\n* stroke\n* severe\u002Funstable angina\n* symptomatic cardiac arrhythmia\n* prolonged QTcF ≥ Grade 3 (i.e., \\> 500 msec)\n* heart failure ≥ Class III as defined by the New York Heart Association (NYHA) guidelines\n* CTCAE version 5.0 grade 3 or 4 dyslipidemia at the time of screening, defined as cholesterol\\>400 mg\u002FdL or \\>10.34 mmol\u002FL and\u002For triglycerides\\>500 mg\u002FdL or \\>5.7 mmol\u002FL.\n* Child-Pugh Score greater than Class A\n* Uncontrolled significant active infections (≥ grade 3 according to CTCAE version 5), including active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency Virus (HIV)\n* Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism",{"count":68,"type":21},220,[24],"This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+\u002FHER2- breast cancer and ctDNA relapse.\n\nDuring the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood.\n\nPatients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.",[72,73,74,75],"ER-positive Breast Cancer","HER2-negative Breast Cancer","Stage IIB Breast Cancer","Stage III Breast Cancer","2026-05-13",{"date":78,"type":50},"2026-05-15",{"date":80,"type":50},"2023-12-15",{"date":82,"type":21},"2035-11-01",{"name":84,"class":85},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",109,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100430550","phase-2-trial-of-pre-operative-neratinib-and-endocrine-therapy-with-trastuzumab-in-er-positive-her-2-positive-breast-cancers-100430550","NCT04886531","Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers","An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141","Inclusion Criteria:\n\nSubject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age ≥ 18 years at the time of consent.\n* Postmenopausal females. NOTE: Postmenopausal status defined as: prior bilateral oophorectomy, Age ≥ 60 years, or Age \\\u003C 60 years and amenorrhea for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or an estradiol level in postmenopausal ranges per local reference range.\n* ECOG Performance Status of 0-2 within 28 days prior to registration.\n* Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm\n* HER2-positive (by the most recent ASCO-CAP criteria)\n* ER positive (≥ 10%). NOTE: There is no requirement for PR status; PR positive or negative allowed.\n* Resectable breast cancer in which pre-operative therapy is appropriate (T \\> 10mm and\u002For node-positive).\n* Archival tissue from the diagnostic pre-treatment biopsy is required. This sample should be identified at screening and shipped by Week 4. If archival tissue is not available, the subject is not eligible for the study.\n* Agreeable to repeat breast biopsy at 3 weeks after initiation of treatment.\n* Candidate for either letrozole or anastrozole, as determined by the treating physician\n* Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) documented within 4 weeks prior to the study treatment.\n* Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.\n\n  * Hematological\n\n    * Platelet count ≥100,000\u002FuL\n    * Absolute Neutrophil Count (ANC) ≥1500\u002FuL\n    * Hemoglobin (Hgb) ≥10 g\u002FdL\n  * Renal\n\n    ---Calculated creatinine clearance: CrCl ≥30 mL\u002Fmin using the Cockcroft-Gault formula\n  * Hepatic\n\n    * Bilirubin ≤1.5 x upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n    * Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.\n* For patients with known serologic evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.\n* Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.\n\nExclusion Criteria:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n* Locally advanced or inflammatory breast cancer. NOTE: Locally advanced is defined as Stage IIIC or greater.\n* Evidence of metastatic disease. Systemic imaging is not required.\n* Patients 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 not eligible for this trial: exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.\n* Active infection requiring systemic therapy.\n* Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study (see protocol).\n* Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer.\n* Subject has had major surgery within 14 days prior to registration or has not recovered from major side effects of the surgery (tumor biopsy is not considered as major surgery).\n* Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) or significantly impair the ability to swallow capsules\u002Ftablets.\n* Known history of myelodysplastic syndrome or acute myeloid leukemia.\n* Subjects with any of the following conditions:\n\n  * History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration.\n  * Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration.\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration.\n  * Symptomatic congestive heart failure (New York Heart Association III-IV) or documented current cardiomyopathy with left ventricular ejection fraction (LVEF) \\\u003C50%.\n  * Clinically significant cardiac ventricular arrhythmias (e.g. sustained ventricular tachycardia\u002Fventricular fibrillation) or high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block) unless a pacemaker is in place.\n  * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.\n* Any concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise compliance with the protocol.",{"count":95,"type":21},30,[97],"PHASE2","Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.",[27,100,30,101],"HER2-positive Breast Cancer","PR-Positive Breast Cancer","2026-04-02",{"date":104,"type":50},"2026-04-08",{"date":106,"type":50},"2022-07-21",{"date":108,"type":21},"2027-07-21",{"name":110,"class":111},"Ruth O'Regan","OTHER",4,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100545518","phase-3-elacestrant--everolimus-in-patients-erher2--esr1mut-advanced-breast-cancer-progressing-to-et-and-cdk46i-100545518","NCT06382948","Elacestrant + Everolimus in Patients ER+\u002FHER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4\u002F6i.","A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+\u002FHER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4\u002F6 Inhibitors","ADELA","Inclusion Criteria:\n\nPatients will be included in the study only if they meet ALL of the following criteria:\n\n1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status (defined in continuation) and men must be concurrently receiving a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol\u002Ffollicle-stimulating hormone \\[FSH\\] must be confirmed analytically) prior to study randomization and are planning to continue LHRH agonist treatment during the study.\n\n   Post-menopausal women as defined by any of the following criteria:\n   1. Age ≥ 60 years;\n   2. Age \\\u003C 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and\u002For FSH levels within the laboratory's reference range for post-menopausal females;\n   3. Documented bilateral surgical oophorectomy.\n4. Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally recurrent or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n5. Documentation of ER\\[+\\] (≥10% positive stained cells) and HER2\\[-\\] (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines as per local assessment. ER\\[+\\]\u002FHER2\\[-\\] status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease.\n6. Patients with ESR1 mutational status will be determined before patient randomization using Guardant360 CDx (Guardant Health) test.\n\n   Note: Patients with previously determined ESR1 mutation using appropriately validated tests (Guardant360 CDx \\[Guardant Health\\], FoundationOne CDx, FoundationOne Liquid \\[Foundation Medicine Inc\\]) will be eligible for inclusion. This local determination can be performed either in blood or tumor samples.\n7. Radiological or objective evidence of disease progression on prior treatment with a CDK4\u002F6 inhibitor in combination with endocrine therapy for advanced disease after at least 6 months of treatment. Patients receiving CDK4\u002F6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after at least 12 months of treatment but no more than 12 months following CDK4\u002F6 inhibitor treatment completion in this scenario.\n8. Patients must have previously received at least one and no more than two lines of endocrine therapy for ABC. Progression during or within 12 months of adjuvant endocrine therapy is considered as a line of endocrine therapy for advanced disease.\n9. No prior elacestrant or other investigational SERDs, proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), or novel SERM, and\u002For PI3K\u002FAKT\u002FmTOR inhibitors, including everolimus, for advanced disease are permitted.\n\n   Note: Fulvestrant is permitted if treatment was completed administered at least 28 days before randomization.\n10. No prior chemotherapy for advanced disease is allowed.\n11. Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or non-measurable, but evaluable, disease, including bone-only disease with at least one lytic or mixed lytic-blastic bone lesion.\n12. Willingness and ability to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue or block. If a newly obtained baseline biopsy of an accessible tumor lesion is not possible to be obtained prior randomization, an archival tissue sample will be accepted.\n13. Fasting serum cholesterol ≤ 300 mg\u002FdL or 7.75 mmol\u002FL and fasting triglycerides ≤ 2.5 times the upper limit of normal (x ULN).\n14. Adequate bone marrow and organ function:\n\n    1. Hematological (without platelet, red blood cell transfusion, and\u002For granulocyte colony-stimulating factor support within seven days before randomization): absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL; platelet count ≥ 100.0 x109\u002FL; and hemoglobin ≥ 9.0 g\u002FdL.\n    2. Hepatic: Serum albumin ≥ 2.5 g\u002FdL; total serum bilirubin \\\u003C 1.5 x ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN; alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 3 x ULN in patients with liver and\u002For bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x ULN (≤ 3 x ULN in patients with liver metastases).\n    3. Renal: Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL\u002Fmin as calculated by Cockcroft- Gault equation.\n    4. Coagulation: International normalized ratio (INR) ≤ 1.5 x ULN, unless that the patient meets the exception described in the exclusion criteria 16.\n15. Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 (except for toxicities not considered a safety risk for the patient at Investigator's discretion).\n\n    Note: Patients with grade 2 alopecia are allowed.\n16. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before randomization. In addition, they agree to use one highly effective method of birth control 28 days prior to start of treatment until 120 days after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same time period.\n17. Male participants with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception 28 days prior to treatment until 120 days after the last dose of study treatments to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and 120 days after the last dose of study treatments is an acceptable practice if this is the preferred usual lifestyle of the participant.\n18. ECOG performance status of 0-1.\n19. Minimum life expectancy of ≥ 12 weeks at screening.\n\nExclusion Criteria:\n\nAny patient meeting ANY of the following criteria will be excluded from the study:\n\n1. Inability to comply with study and follow-up procedures.\n2. Formal contraindication to endocrine therapy defined as visceral crisis and\u002For rapidly or symptomatic progressive visceral disease.\n3. Current participation in another therapeutic clinical trial.\n4. Treatment with approved or investigational cancer therapy within 14 days prior to randomization except for fulvestrant that must be administered completed at least 28 days before randomization.\n5. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and\u002For leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\u002For progressive growth. Patients with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before randomization.\n6. Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion).\n7. Concurrent malignancy or malignancy within three years before randomization with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.\n8. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances.\n9. History of malabsorption syndrome or other condition that would interfere with enteral absorption (ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass) or results in the inability or unwillingness to swallow pills.\n10. Palliative radiotherapy with a limited field of radiation within two weeks or with wide field of radiation or to more than 30% of the bone marrow within four weeks prior to randomization.\n11. Major surgical procedure or significant traumatic injury within 14 days before randomization or anticipation of need for major surgery within the course of the study treatment.\n12. Clinically relevant cardiovascular\u002Fcerebrovascular disease and\u002For cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    a. Symptomatic pericarditis, unstable angina pectoris, documented myocardial infarction, coronary\u002Fperipheral artery bypass graft, symptomatic cardiac heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV), or cerebrovascular accident including transient ischemic attack within six months before study randomization.\n13. Concurrent uncontrolled atrial fibrillation, other ongoing cardiac dysrhythmias grade ≥ 2 as determined by NCI-CTCAE v.5.0, or prolonged QT Interval Corrected by Fridericia's formula (\\[QTcF\\] \\> 480 msec).\n14. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited, to any of the following:\n\n    1. Massive lung metastatic involvement (e.g., pleural effusion, lymphangitic carcinomatosis, etc.).\n    2. Any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, post Coronavirus disease (COVID-19) pulmonary fibrosis, etc.).\n    3. Any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.).\n    4. Prior pneumonectomy.\n15. History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n16. Coagulopathy or any history of coagulopathy within six months before study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, patients with the following conditions will be allowed to participate:\n\n    1. Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to randomization.\n    2. Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than six months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to randomization.\n17. Concomitant treatment with immunosuppressive agents or chronic corticosteroids use before randomization with the following exceptions: topical applications, inhaled sprays, eye drops, mouthwash, or local injections are allowed. Patients on stable low dose of corticosteroids ( ≤ 10 mg\u002Fday of prednisone or equivalent) for at least two weeks before randomization are also permitted.\n18. Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary\u002Fherbal supplements (e.g., St. John's wort), and\u002For foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, and\u002For foods are discontinued for at least five half-lives or 14 days (whichever is shorter) prior to randomization and for the duration of the study.\n19. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n20. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Any other active uncontrolled infection at the time of screening is not allowed.\n21. Known substance abuse or any other concurrent severe and\u002For uncontrolled psychiatric or medical condition that would, in the Investigator's judgment, contraindicate patient participation.",{"count":122,"type":21},240,[24],"This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive\u002Fhuman epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.\n\nThe main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive\u002FHER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.\n\nRigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.",[126,72,73,127],"Advanced Breast Cancer","ESR1 Gene Mutation",[129,130,131,132,133],"ER-positive","HER22-negative","ESR1-mutation","CDK4\u002F6-inhibitor","Selective endocrine receptor degrader (SERD)","2026-03-30",{"date":136,"type":50},"2026-04-03",{"date":138,"type":50},"2024-12-05",{"date":140,"type":21},"2028-04",{"name":142,"class":111},"MedSIR",99,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":152,"minAge":18,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100630031","supporting-health-including-endocrine-treatment-for-long-duration-100630031","NCT07482384","Supporting Health Including Endocrine Treatment for Long Duration","Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention","SHIELD","Inclusion criteria\n\nParticipants will be eligible if they meet the following eligibility criteria:\n\n* Female\n* Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer\n* Premenopausal\n* In active treatment (including long-term endocrine therapy) at the time of enrollment\n* Able to speak, understand and read English\n* Access to a US-based mobile phone number\n* Cognitively able to complete study requirements\n* Ability to access medical records from treating hospital (DFCI)\n* Willing to provide cell phone number and\u002For email address and willing to receive email, mobile push notifications, and\u002For text messages from the study team\n\nExclusion criteria\n\nParticipants will be ineligible if they meet any of the following criteria:\n\n* Individuals under age 18 or over age 50 at initial breast cancer diagnosis\n* Patients with breast cancer who are not being treated with ET\n* Stage IV or metastatic breast cancer\n* Pregnant patients\n* Individuals who do not have a US mobile phone number\n* Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.","FEMALE","49 Years",{"count":95,"type":21},[156],"NA","This research is being done to pilot an intervention which aims to test a new web- and mobile application (\"app\")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.",[27,159,160,30,101],"Breast Cancer - Female","Breast Carcinoma",[162,163,164,165,150],"Breast cancer","Breast cancer female","Breast carcinoma","ER+","NOT_YET_RECRUITING","2026-03-16",{"date":169,"type":50},"2026-03-19",{"date":171,"type":21},"2026-05",{"date":173,"type":21},"2027-05",{"name":175,"class":111},"Dana-Farber Cancer Institute",1,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100517376","phase-3-op-1250-palazestrant-vs-standard-of-care-for-the-treatment-of-erher2--advanced-breast-cancer-100517376","NCT06016738","OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4\u002F6 Inhibitor Therapy (OPERA-01)","OPERA-01","Key inclusion criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease or bone-only disease).\n* Previously received a CDK4\u002F6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nKey exclusion criteria:\n\n* Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.\n* Previously received chemotherapy in the advanced\u002Fmetastatic setting.\n* Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.\n* History of allergic reactions to study treatment.\n* Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.\n* Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.",{"count":186,"type":21},510,[24],"This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4\u002F6 inhibitor.",[27,126,29,30,31],"2026-03-11",{"date":192,"type":50},"2026-03-13",{"date":194,"type":50},"2023-11-16",{"date":196,"type":21},"2027-09-30",{"name":56,"class":57},233,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":176},"100462764","phase-2-fulvestrantabemaciclib-with-run-in-of-fulvestrant-in-er-positive-her2-negative-metastatic-breast-cancer-100462764","NCT05305924","Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer","Phase II Trial Of Fulvestrant Plus Abemaciclib In Er-Positive, Her2-Negative Metastatic Breast Cancer Immediately After Failure Of A Cdk4\u002F6 Inhibitor","Inclusion Criteria:\n\n1. Male or Female \\>18 years of age on the day of informed consent signing.\n2. Progression on a CDK4\u002F6 inhibitor in combination with an AI immediately prior to the enrollment on this study\n3. Histologically confirmed ER-positive, HER2-negative metastatic breast cancer. ER-positive is defined as ≥1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show:\n\n   * IHC 1+ or 0\n   * In situ hybridization negative based on:\n\n     * Single-probe average HER2 copy number \\\u003C4.0 signals\u002Fcell\n     * Dual-probe HER2\u002FCEP17 ratio \\\u003C2.0 with an average HER2 copy number \\\u003C4.0 signals\u002Fcell.\n4. Measurable disease according to the RECIST 1.1 or bone-only disease.\n5. Postmenopausal status or receiving ovarian ablation with a gonadotropin-releasing hormone (GnRH) agonist. Postmenopausal status is defined by any one of the following criteria:\n\n   * Prior bilateral oophorectomy\n   * Age ≥55 years\n   * Age \\\u003C55 years and amenorrheic for at least 12 months (spontaneous cessation of menses for 12 consecutive months or more in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone and estradiol levels in the postmenopausal range without an alternative cause If the patient does not meet criteria for postmenopausal status but is receiving ovarian ablation therapy with a GnRH agonist, the patient is eligible for this trial, provided that the GnRH agonist is started at least 2 weeks prior to the first dose of trial treatment.\n6. Eastern Cooperative Oncology Group performance status of 0 or 1.\n7. Life expectancy ≥6 months.\n8. 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 randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy). Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 21 days is required between end of radiotherapy and randomization.\n9. Adequate organ function:\n\n   * Absolute neutrophil count ≥1500\u002FµL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n   * Platelets ≥100,000\u002FµL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Hemoglobin ≥9 g\u002FdL (without blood transfusion)\n   * White blood cell count \\>2,500\u002FµL and \\\u003C15,000\u002FµL\n   * Lymphocyte count ≥500\u002FµL\n   * Serum bilirubin ≤1.5x upper limit of normal (ULN; patients with known Gilbert's disease who have serum bilirubin level ≤3 x ULN may be enrolled)\n   * Serum transaminases (aspartate transaminase \\[AST\\] or alanine transaminase \\[ALT\\]) activity ≤3.0 x ULN with normal alkaline phosphatase (\\[ALP\\]; patients with liver metastases ≤5 x ULN) OR AST and ALT ≤1.5 x ULN with ALP \\>2.5 x ULN\n   * International normalized ratio and activated partial thromboplastin time ≤1.5 x ULN\n   * Serum creatinine at or below the institutional normal value.\n10. Able to swallow oral medication.\n11. Patients who are made postmenopausal through use of GNRH agonists must be willing to use an adequate method of contraception for the course of the trial through 1 year after the last dose of trial treatment.\n12. Patients who are made postmenopausal through use of GNRH agonists should have a negative serum pregnancy (β-human chorionic gonadotropin) within 7 days prior to trial treatment administration.\n13. Willing and able to provide written informed consent\u002Fassent for the trial.\n\nExclusion Criteria:\n\n1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment administration.\n2. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent. Note: If the patient received major surgery, she must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting the trial treatment.\n3. The patient has had major surgery within 14 days prior to starting the study.\n4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n5. The patient has 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).\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 is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n8. Concurrent use of strong cytochrome P450 (CYP)3A inhibitors or inducers.\n9. Hypersensitivity to fulvestrant, abemaciclib, or any of their excipients.\n10. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal surgery disease, or an unknown reason.\n11. Has a bleeding disorder or currently taking anticoagulants.\n12. Has active hepatitis B (detectable hepatitis B surface antigen) or active hepatitis C infection (detectable hepatitis C RNA).\n13. 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.\n14. 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.\n15. Documented brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Patients with previously diagnosed brain metastases are eligible if they have completed treatment at least one month prior to trial treatment administration, are neurologically stable, and have recovered from effects of radiotherapy or surgery.\n\n    * Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥2 weeks before trial treatment administration.\n    * Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery, or a combination as was deemed appropriate by the treating physician.\n    * Patients who meet the above criteria and are clinically stable on anticonvulsant medication are eligible only if their anticonvulsant does not alter hepatic CYP activity in a way that might interfere with the metabolism of abemaciclib.\n16. Have received any live vaccination within 28 days of trial treatment administration.\n17. History within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n18. Pregnant or breastfeeding.",{"count":207,"type":21},28,[97],"The study will investigate if CDK4\u002F6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.",[211,73],"ER-Positive Breast Cancer",[213,214,215,216],"Fulvestrant","Abemaciclib","CDK4\u002F6 Inhibitor","Aromatase Inhibitor","2026-01-26",{"date":219,"type":50},"2026-01-28",{"date":221,"type":50},"2021-02-25",{"date":223,"type":21},"2027-12-01",{"name":225,"class":111},"The Methodist Hospital Research Institute",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},"100478356","phase-1-phase-1b-study-of-op-1250-palazestrant-in-combination-with-ribociclib-alpelisib-everolimus-or-atirmociclib-in-er-her2--breast-cancer-100478356","NCT05508906","Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer","A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4\u002F6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and\u002For Metastatic ER Positive, HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Female or male aged \\>18 years.\n* Willing and able to participate and comply with all study requirements.\n* Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).\n* ER+\u002FHER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.\n* Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiological examinations (eg. bone scan, PET\u002FCT, CT, MRI) even if lesions are non-measurable according to RECIST 1.1.\n* Life expectancy ≥6 months, as judged by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Has received no more than 1 prior hormonal regimen (Treatment Group 1). Has received no more than 2 prior hormonal regimens (Treatment Group 2 and Treatment Group 3) . Has received no more than 2 prior hormonal regimens for metastatic disease in Part 1 (Dose Escalation) and no more than 1 prior hormonal regimes in Part 2 (Dose Expansion) for metastatic disease, regardless of type of endocrine agent (Treatment Group 4) for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4\u002F6 inhibitors are allowed in all treatment groups. For subjects in Treatment Group 4, no prior chemotherapy for metastatic breast cancer is allowed.\n* Has received no more than 1 prior chemotherapy (which includes antibody drug conjugates) for locally advanced or metastatic breast cancer.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* History of cerebral vascular disease within 6 months prior to the first administration of study drug dose.\n* History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator.\n* History of pneumonitis or interstitial lung disease.\n* Leptomeningeal disease or spinal cord compression.\n* Medical history or ongoing gastrointestinal disorders that could affect absorption of oral therapeutics.\n* Known human immunodeficiency virus infection.\n* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis.\n* History of severe cutaneous reaction, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms.\n* Active infection or at a high risk of developing a serious infection (e.g. participants with immunodeficiencies, uncontrolled diabetes mellitus, uncontrolled heart disease, poor general health, poor nutritional status).\n* Has clinically significant co-morbidities, such as, psychiatric disease, or any other condition that could impact the ability of the subject to participate in this study or otherwise has the potential to confound the study results.\n* Have received prior treatment with OP-1250.\n* Have received prior treatment with approved or investigational PI3K inhibitor (Treatment Group 2) or mTOR inhibitor (Treatment Group 3).",{"count":234,"type":21},190,[236],"PHASE1","This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows:\n\nTreatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).\n\nTreatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).\n\nTreatment Group 3: Palazestrant (OP-1250) in combination with everolimus.\n\nTreatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.",[29,72,73,27,28],"2025-10-20",{"date":241,"type":50},"2025-10-22",{"date":243,"type":50},"2022-08-31",{"date":245,"type":21},"2028-01-31",{"name":56,"class":57},16,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":263,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"100529629","phase-2-dato-base-datopotamab-deruxtecan-for-breast-cancer-brain-metastases-100529629","NCT06176261","DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","Inclusion Criteria :\n\n* Metastatic breast cancer that is pathologically confirmed to be HER2-negative according to 2018 ASCO\u002FCAP guidelines 55.\n* Radiological confirmation of metastatic disease.\n* Cohorts A and B: Presence of newly diagnosed brain metastases or brain metastases progressing after prior local and\u002For systemic therapy.\n* Cohorts A and B: Participants must have a baseline MRI of the brain performed with and without gadolinium contrast, and must have central nervous system metastases with at least one measurable brain metastasis ≥ 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy and\u002For systemic therapy (in the opinion of the treating physician). For cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Cohorts C: Radiological evidence of evaluable leptomeningeal disease and clinical diagnosis of LMD per treating investigator. A positive CSF cytology is not required.\n* Cohort A: prior progression to treatment with at least one line of endocrine treatment (with or without CDK4\u002F6 inhibition) in the metastatic setting is mandatory. Patients experiencing recurrence during adjuvant endocrine treatment will be also considered eligible for the trial. There is no limit on the number of prior lines acceptable for the purpose of enrollment in this study.\n* Cohort B and C: no prior treatment is required (i.e., previously untreated patients are eligible). There is no limit on the number of prior lines of therapy acceptable for the purpose of enrollment in this study.\n* Participants may have measurable or non-measurable extracranial disease. Participants are NOT required to have extracranial disease, but must have imaging done to document disease status at baseline.\n* Age ≥ 18 years.\n* ECOG Performance Status 0-2\n* Participants must have adequate treatment washout period before registration, defined as \\> 4 weeks from major surgery, \\> 2 weeks from radiation treatment. For weekly chemotherapy regimens, \\> 2 weeks from chemotherapy; for every 3 weekly regimens, \\> 3 weeks from chemotherapy. At least 2 weeks from other systemic or targeted or investigational therapies (other than endocrine therapy) for breast cancer. No washout is required for endocrine therapy (e.g. aromatase inhibitors, tamoxifen, fulvestrant) but patients should discontinue prior to start of protocol therapy. Patients on ovarian suppression are allowed (but not required) to continue ovarian suppression at the discretion of their treating provider.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n* Adequate organ function as defined by the following values:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL. Red blood cell\u002Fplasma transfusion is not permitted within 1 week prior to screening assessment.\n  * Absolute neutrophil count ≥1,500\u002Fmm3. Granulocyte colony-stimulating factor administration is not permitted within 1 week prior to screening assessment.\n  * Platelets ≥100,000\u002Fmm3. Platelet transfusion is not permitted within 1 week prior to screening assessment.\n  * Total bilirubin ≤ 1.5 institutional ULN if no liver metastases; or ≤ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN OR ≤ 5.0 x institutional ULN for patients with documented liver metastases\n  * Serum creatinine ≤ 1.5 mg\u002FdL (or glomerular filtration rate ≥ 30 ml\u002Fmin as determined by the Cockcroft-Gault equation)\n* Participants with a history of chronic viral conditions such as HIV, Hepatitis B\u002FC, should not be systemically excluded but have thoughtful consideration of inclusion, unless safety is a concern. Testing for these conditions is not required at baseline.\n* Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days of initiating protocol therapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Visceral crisis or impending visceral crisis\n* CNS complications for whom urgent neurosurgical intervention is indicated (i.e., resection, shunt placement)\n* Indication for immediate local therapy to CNS lesion(s) as defined by local standard\n* Evidence of significant (i.e., symptomatic) intracranial hemorrhage\n\n  -\\> 2 seizures within 4 weeks prior to study entry (registration)\n* Ongoing\u002Fpersistent toxicities caused by previous anti-cancer therapy (except alopecia) not yet improved to Grade ≤ 1 OR baseline prior to study entry (registration)\n* Known contraindication to MRI (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity). However, for cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Concurrent administration of other anti-cancer therapy during the course of this study is not allowed. Concurrent use of supportive care medications is allowed, and certain medications are required (see Section 5.1).\n* Uncontrolled intercurrent illness, including (but not limited to) active infection, severely compromised pulmonary function, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ischemic heart disease, myocardial infarction within the previous six months, gastric or duodenal ulceration diagnosed within the previous six months, chronic liver or renal disease, or severe malnutrition. Note that if a patient has controlled diabetes mellitus, but is unable to monitor blood glucose at home, they will be excluded from the trial.\n* Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (\\>4 mg daily dexamethasone (or bioequivalent)) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* A history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.\n* A history of malignancy other than breast cancer, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for ≥ 3 years.\n* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to the initiation of protocol therapy, or anticipation of need for a major surgical procedure during the study.\n* Clinically significant corneal disease.\n* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of datopotamab deruxtecan.\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Negative pregnancy test (urine and\u002For serum) is required for women of childbearing potential. Pregnant or lactating women are excluded from participation due to potential teratogenic effects of study drug.\n* Female participants must be either:\n\n  * post-menopausal for at least 1 year\n  * surgically sterile, or\n  * if of childbearing potential and sexually active with a non-sterilized male partner, must agree to use one highly effective form of birth control for the entire treatment period and for at least 7 months after the last dose of datopotamab deruxtecan (see Section 5.4 for complete list of highly effective birth control methods).\n* Female participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Female participants must refrain from breastfeeding while on study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception (see Section 5.4 for complete list of highly effective birth control methods) from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.",{"count":256,"type":21},58,[97],"The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.\n\nThe name of the study drug used in this research study is:\n\nDatopotamab deruxtecan (a type of antibody-drug conjugate)",[27,260,261,30,73,31,262],"Breast Cancer Female","Metastatic Triple-Negative Breast Carcinoma","ER-negative Breast Cancer",[27,260,261,30,264,31,265],"HER2 Negative Breast Cancer","ER Negative Breast Cancer","2025-07-28",{"date":268,"type":50},"2025-07-30",{"date":270,"type":50},"2024-01-08",{"date":272,"type":21},"2029-01-01",{"name":274,"class":111},"Sarah Sammons, MD",3,{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":152,"minAge":18,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":284,"phases":4,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":176},"100469730","role-of-the-immune-environment-in-response-to-therapy-in-breast-cancer-100469730","NCT05396612","Role of the Immune Environment in Response to Therapy in Breast Cancer","Inclusion criteria:\n\nWomen 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System.\n\nExclusion criteria:\n\nMales Children Pregnant individuals",{"count":283,"type":21},300,"OBSERVATIONAL","This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.",[27,30,73,287],"TNBC - Triple-Negative Breast Cancer",[289],"Immune microenvironment","2025-07-02",{"date":292,"type":50},"2025-07-08",{"date":294,"type":50},"2022-10-03",{"date":296,"type":21},"2032-12-31",{"name":298,"class":111},"Abramson Cancer Center at Penn Medicine",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":329,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen",{"count":308,"type":21},124,[236],"I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[100,312,29,313,314,315,316,73,317,318,319,320,321,322,323,324,325,326,327,30,328],"Metastatic Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","Triple Negative Breast Cancer","HR Positive","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","Solid Tumor","Solid Tumor, Adult","Solid Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","PR-positive Breast Cancer",[330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":366,"type":50},"2025-04-04",{"date":368,"type":50},"2023-02-15",{"date":370,"type":21},"2029-12-30",{"name":372,"class":111},"QuantumLeap Healthcare Collaborative",7,{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":152,"minAge":4,"maxAge":4,"enrollmentInfo":382,"targetDuration":383,"studyType":284,"phases":4,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":176},"100413196","to-identify-primary-resistance-to-cdk46-inhibitors-in-breast-cancer-100413196","NCT04660435","To Identify Primary Resistance to CDK4\u002F6 Inhibitors in Breast Cancer","Identification and Monitoring of Resistance to First-line Treatment with CDK 4\u002F6 Inhibitors in Combination with Aromatase Inhibitors in Patients with Metastatic Luminal Breast Cancer Through Non-invasive Biomarkers","TIRESIAS","Inclusion Criteria:\n\n1. Women aged 18 years or older, with a diagnosis of metastatic breast cancer\n2. ER-positive and HER2-negative disease as assessed locally either on primary tumor tissue or on a biopsy of a metastasis\n3. The patient has not received any prior systemic therapy for metastatic breast cancer (may have received prior hormonal therapy or chemotherapy in the neo\u002Fadjuvant setting)\n4. The patient is candidate to receive first-line therapy with an aromatase inhibitor (AI) and a CDK4\u002F6 inhibitor per local clinical practice\n5. The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable).\n\n   Note: Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size.\n6. Hystologic material from one formalin-fixed, paraffin-embedded (FFPE) tumor block from a diagnostic core or excisional biopsy of a metastatic lesion, taken before study entry must be provided (patients with bone-only disease will be accepted into the trial without a biopsy of the metastatic site). Hystologic material from an additional biopsy (core or excisional) taken at time of disease progression on the study treatment must also be provided, if clinically feasible. When available, hystologic material from an FFPE tumor block from the primary breast cancer must also be submitted.\n7. The patient agrees to provide blood samples. at the trial specified time points\n\nExclusion Criteria:\n\n1. Patients with metastatic disease isolated to the central nervous system (CNS) without metastatic involvement of any other site, unless surgical excision of CNS metastasis has been performed and the tumor tissue is available for the study.\n2. Previous or current non-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix and\u002For adequately treated basal cell or squamous cell carcinoma of the skin",{"count":58,"type":21},"5 Years","This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4\u002F6 inhibitor as per standard clinical practice.\n\nBlood and tissue samples will be collected for biomarker analysis, including thymidine kinase1 activity, gene expression signatures and circulating tumor DNA.",[29,30,73],[387,388,389,214,41,390,391,392],"CDK 4\u002F6 inhibitors","Thymidine Kinase","Palbociclib","circulating tumour DNA","gene expression signatures","aromatase inhibitors","2025-02-25",{"date":395,"type":50},"2025-02-26",{"date":397,"type":50},"2020-09-01",{"date":399,"type":21},"2026-12-01",{"name":401,"class":111},"Fondazione Sandro Pitigliani",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":152,"minAge":409,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":176},"100494598","phase-2-immunotherapy-hormone-therapy-and-akt-inhibitor-for-premenopausal-er-positive-mbc-100494598","NCT05720260","Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC","A Randomized, Phase II Study for Premenopausal Metastatic or Locally Advanced Breast Cancer Patients: Capivasertib, Goserelin, Fulvestrant With\u002FWithout Durvalumab, Versus Goserelin, Fulvestrant, and Durvalumab, Versus Goserelin\u002F Fulvestrant.","Inclusion criteria\n\n1. A histological confirmed ER positive (\\>1%) invasive breast cancer.\n2. Locally advanced or metastatic disease with at least one measurable target lesion\n3. Patients who had not received chemotherapy for locally advanced or metastatic disease\n4. Patients have to be (i) either primary resistant to hormonal therapy defined as recurrence developed within 2 years of adjuvant hormonal therapy (ii) or resistant to prior hormonal therapy (failed ≤ 2lines of hormonal therapy for locally advanced or metastatic breast cancer)\n5. Patients must be premenopausal or perimenopausal women according the clinical menstrual history or E2 \u002F FSH level based on local hospital guidance. Patient with menopausal status cannot be determined due to ongoing LHRH agonist treatment is allowed if evidence of premenopausal status prior to patients' LHRH agonist usage can be provided.\n6. ECOG 0-1\n7. Patients must have adequate organ and marrow reserve measured within 14 days(within screening period ) prior to randomization as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL;\n   * Absolute neutrophil count ≥ 1,500 \u002FL;\n   * Platelets ≥ 100,000\u002FL;\n   * Total bilirubin ≤ 1.5 x upper normal limit;\n   * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)\u002FALT(SGPT) ≤ 5 x upper normal limit is allowed;\n   * Serum creatinine ≤ 1.5mg\u002FdL or creatinine clearance ≧50ml\u002Fmin;\n   * aPTT \\\u003C 1.5 x upper normal limit (unless on therapeutic anti-coagulation);\n   * Proteinuria ≤ 1+ with urine dipstick, if \\> 1+, 24-hour urine protein must be ≤ 1 g.\n8. Age older than 20-year-old.\n9. All women of childbearing potential must have a negative pregnancy test obtained within 7 days before starting therapy. Patients must not be breastfeeding.\n10. Patients with reproductive potential must use effective contraception (hormone or barrier method of birth control) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.\n11. Patients (or a surrogate) must be able to comply with study procedures and to give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP). The patients (or a surrogate) must be able to provide of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n12. Body weight \\>30 kg\n13. Must have a life expectancy of at least 12 weeks Exclusion criteria\n\nPatients fulfilled ANY of the following criteria will be excluded from this trial:\n\n1. Prior therapy with capivasertib, fulvestrant, anti-PD1 or anti-PDL1 immunotherapy\n2. Prior chemotherapy for locally advanced or metastatic breast cancer.\n3. Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment\n4. The tumor is HER-2 positive by IHC 3+ or IHC 2+\u002FISH positive.\n5. Patients have active brain metastases or spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment\n6. Other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.\n7. Psychiatric illness or social situation that would preclude study compliance.\n8. Serious non-healing wound, ulcer, or bone fracture.\n9. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n10. Prior minor surgery within 7 days.\n11. History of allergic reaction to compounds of similar chemical composition to the study drugs.\n12. Pregnancy or lactation.\n13. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment\n14. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n15. Known to have tested positive for human immunodeficiency virus\n16. History of allogenic organ transplantation.\n17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion: a) Patients with vitiligo or alopecia; b) Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; c)Any chronic skin condition that does not require systemic therapy; d) Patients without active disease in the last 5 years may be included but only after consultation with the study physician; e)Patients with celiac disease controlled by diet alone.\n18. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib.\n19. History of another primary malignancy except for: a) Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence; b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c)Adequately treated carcinoma in situ without evidence of disease\n20. History of leptomeningeal carcinomatosis.\n21. Previous allogeneic bone marrow transplant or solid organ transplant.\n22. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n23. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n24. Any of the following cardiac criteria at screening:\n\n    * Mean resting corrected QT interval (QTc) \\>470 msec obtained from 3 consecutive ECGs\n    * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)\n    * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval\n    * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2\n    * Uncontrolled hypotension - SBP \\\u003C90 mmHg and\u002For DBP \\\u003C50 mmHg\n    * Cardiac ejection fraction outside institutional range of normal or \\\u003C50% (whichever is higher) as measured by echocardiogram.\n25. Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:\n\n    * Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment\n    * HbA1c ≥8.0% (63.9 mmol\u002Fmol)\n26. Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment\n27. Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and\u002For CYP2D6 with a narrow therapeutic window within 1 week prior to the first dose of study treatment.\n28. Participation in another clinical study with an investigational medicinal product (IMP) administered in the last 30 days or 5 half-lives, whichever is longer\n29. History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant, durvalumab, goserelin or drugs with a similar chemical structure or class to the above-mentioned drugs\n30. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.","20 Years",{"count":411,"type":21},42,[97],"This is an open-label randomized phase II study in estrogen receptor positive locally advanced or metastatic breast cancer patients. The main inclusion population are either luminal subtype B by PAM50 analysis or failed less than 2 lines of hormonal therapy for locally advanced or metastatic breast cancer. The subjects have to be premenopausal or perimenopausal and are not allowed to receive any systemic chemotherapy for their locally advanced or metastatic breast cancer. Eligible subjects will be randomized into goserelin\u002F fulvestrant\u002F durvalumab (Arm A), goserelin\u002F fulvestrant\u002F capivasertib\u002F durvalumab (Arm B), or goserelin\u002F fulvestrant\u002F capivasertib (Arm C) at a 1:1:1 ratio. The primary endpoint is objective response rate (ORR) of the whole other three arm compared to historical goserelin\u002F fulvestrantcontrol arm. The major secondary endpoint will be progression-free survival or ORR compared among different treatment arms.",[415,29,30],"Premenopausal Breast Cancer","2024-06-07",{"date":418,"type":50},"2024-06-10",{"date":420,"type":50},"2023-01-17",{"date":422,"type":21},"2027-01-31",{"name":424,"class":111},"National Taiwan University Hospital"]