[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-receptor-positive-malignant-neoplasm-of-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-receptor-positive-malignant-neoplasm-of-breast":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,86,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326",false,"NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},399,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[26,27,28,29,30,31,32,33,34],"Advanced Solid Tumor","Advanced Breast Cancer","Metastatic Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[36,37,38,39,40,33,41,42],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer","RECRUITING","2026-05-26",{"date":46,"type":47},"2026-05-27","ACTUAL",{"date":49,"type":47},"2023-12-01",{"date":51,"type":20},"2028-11",{"name":53,"class":54},"BeOne Medicines","INDUSTRY",63,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100364843","screening-magnetic-resonance-imaging-of-the-brain-in-patients-with-breast-cancer-100364843","NCT04030507","Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer","Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First\u002FSecond Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and\u002For study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.\n* Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic\u002Frecurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.\n* Participants must be age 18 years or older.\n* Participants must have a life expectancy of greater than 12 weeks.\n* Participants must be willing to undergo study procedures.\n* The effects of gadolinium \u002F other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n* Participants must possess the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).\n* Participants who have chronic kidney disease stage IV-V or end stage renal disease.\n* Participants with a history of anaphylactic reactions to gadolinium.\n* Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.\n* Patients with a prior diagnosis of brain metastases",{"count":64,"type":20},214,[66],"NA","This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).",[69,70,71,31,72,28],"Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Cancer","Inflammatory Breast Cancer",[69,70,71,31,72,74],"Metastatic breast cancer","2026-03-17",{"date":77,"type":47},"2026-03-19",{"date":79,"type":47},"2019-07-26",{"date":81,"type":20},"2028-02",{"name":83,"class":84},"Brigham and Women's Hospital","OTHER",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":98,"conditions":99,"keywords":107,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100596217","phase-4-a-study-of-revaree-plus-in-people-with-breast-cancer-100596217","NCT07042581","A Study of Revaree Plus in People With Breast Cancer","Evaluation of Revaree Plus in Women With Breast Cancer","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing informed consent.\n* Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC\n* Able to complete study questionnaires in English or Spanish\n* Breast cancer patients must have completed primary therapy (surgery, and\u002For chemotherapy, and\u002For radiation therapy) or currently on maintenance therapy\n* Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM)\n* Currently have no clinical evidence of disease\n* Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \\[pain with intercourse or examination\\])\n* A total score of 4 or greater in VAS\n* Without history of other cancers (excluding non-melanoma skin cancer)\n* Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Vaginal bleeding of unknown etiology within 12 months of study entry\n* Currently taking hormone replacement therapy \\[local or systemic\\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* No known allergies to any ingredients in 10mg HLA suppository","FEMALE",{"count":95,"type":20},60,[97],"PHASE4","The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.",[69,100,101,102,103,104,105,106,29,30,31],"Stage 0 Breast Cancer","Stage I Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer","Stage 0 Breast Carcinoma","Stage II Breast Carcinoma","Stage III Breast Carcinoma",[69,100,101,102,103,108,109,110,111,112,113,114],"Stage 0 hormone receptor positive breast cancer","Stage I hormone receptor positive breast cancer","Stage II hormone receptor positive breast cancer","Stage III hormone receptor positive breast cancer","Revaree","24-374","Memorial Sloan Kettering Cancer Center","2026-02-04",{"date":117,"type":47},"2026-02-06",{"date":119,"type":47},"2025-06-20",{"date":121,"type":20},"2029-06-20",{"name":114,"class":84},7,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":174,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":133,"type":20},3500,"OBSERVATIONAL","PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[137,138,139,140,141,142,143,69,144,145,146,147,148,149,150,151,152,153,154,155,156,30,157,33,31,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Carcinoma","Breast Diseases","Breast Neoplasms","Breast Neoplasms, Male","Breast Cancer With Metastatic Bone Disease","Breast Cancers","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[175,176,169,170,171,177,178,28],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","2025-01-28",{"date":181,"type":47},"2025-02-03",{"date":183,"type":47},"2023-05-01",{"date":185,"type":20},"2040-12-31",{"name":187,"class":84},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24]