[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hrher2-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hrher2-breast-cancer":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100648157","phase-2-fulvestaciclib-combined-with-anti-her2-and-endocrine-therapy-for-hrher2-advanced-breast-cancer-100648157",false,"NCT07716046","Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+\u002FHER2+ Advanced Breast Cancer","Efficacy and Safety of Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for First-line Maintenance or Upfront Chemo-Free Treatment in HR+\u002FHER2+ Advanced Breast Cancer: A Multicenter, Open-label, Randomized Controlled Phase II Study","FACET","Inclusion Criteria:\n\n* Age ≥ 18 years, with inoperable locally advanced or recurrent\u002Fmetastatic breast cancer not amenable to curative-intent therapy.\n* Histologically or cytologically confirmed hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. HR+ is defined as estrogen receptor (ER) and\u002For progesterone receptor (PR) positivity with ≥1% of invasive tumor cells positive by immunohistochemistry (IHC). HER2+ is defined as IHC 3+ or IHC 2+ with in situ hybridization (ISH) positivity.\n* No prior systemic therapy for advanced breast cancer, including endocrine therapy, chemotherapy, anti-HER2 therapy, or any CDK4\u002F6 inhibitor.\n* Patients may have received neoadjuvant or adjuvant therapy. If prior endocrine therapy was received in the neoadjuvant\u002Fadjuvant setting, the disease-free interval from completion of endocrine therapy to randomization must be ≥12 months. If prior anti-HER2 therapy was received, the disease-free interval from completion of anti-HER2 therapy to randomization must be ≥6 months.\n* Patients with stable central nervous system (CNS) metastases (meeting all the following criteria: no disease progression on screening imaging after local therapy; at least 3 weeks from completion of local CNS therapy to Cycle 1 Day 1; no requirement for medication to control symptoms) or asymptomatic CNS metastases are eligible.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Any menopausal status. Postmenopausal status is defined as: a. bilateral oophorectomy; b. age ≥60 years; c. age \\\u003C60 years with amenorrhea for \\>1 year in the absence of chemotherapy, tamoxifen, toremifene, or ovarian function suppression, and with serum FSH and estradiol levels within the postmenopausal range. For patients \\\u003C60 years on tamoxifen or toremifene with amenorrhea, serum FSH and estradiol levels must be within the postmenopausal range on consecutive measurements.\n* At least one evaluable lesion per RECIST 1.1 (measurable and\u002For non-measurable lesion).\n* For women of childbearing potential: negative serum or urine pregnancy test within 7 days prior to randomization, and agreement to use adequate contraception during study treatment and for 6 months after the last dose of fulvestaciclib.\n* Voluntarily sign the informed consent form (ICF), understand the study, and be willing to comply with all study procedures and follow-up.\n* Adequate bone marrow and organ function defined as:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Hemoglobin ≥90 g\u002FL (no red blood cell transfusion within 14 days prior to randomization); Platelet count ≥75 × 10⁹\u002FL; Serum total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN (or ≤5 × ULN in the presence of liver metastases); Serum creatinine ≤1 × ULN or calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula); Baseline left ventricular ejection fraction (LVEF) ≥50%.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer.\n* Leptomeningeal disease.\n* Active brain metastases (patients with asymptomatic brain metastases, or clinically stable and not requiring steroids or other CNS-directed therapy for ≥4 weeks are eligible).\n* Diagnosis of any other malignancy, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that has been definitively treated.\n* Known severe hypersensitivity to any component of the study drugs.\n* Myocardial infarction within 6 months prior to first dose; uncontrolled cardiac arrhythmias (QTc interval ≥470 ms by Fridericia's formula); New York Heart Association (NYHA) Class III-IV cardiac insufficiency; LVEF \\\u003C50% on echocardiography; or clinically significant pleural effusion, pericardial effusion, or ascites requiring intervention.\n* Dysphagia, active gastrointestinal disease, major gastrointestinal surgery, malabsorption syndrome, or any other condition that may interfere with the absorption of study drugs.\n* Known active infection, including hepatitis B (HBsAg positive with HBV DNA ≥1×10⁴ copies\u002FmL or ≥2000 IU\u002FmL), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection.\n* Major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody therapy, or other systemic antitumor therapy within 30 days prior to the first dose, or any therapy that the investigator considers may interfere with the efficacy of study drugs.\n* Concurrent use of other investigational drugs or therapies.\n* Planned or prior organ or bone marrow transplantation.\n* Known history of substance abuse or drug addiction.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4\u002F6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and pertuzumab, HP) and endocrine therapy (ET) in hormone receptor-positive (HR+) and HER2-positive advanced breast cancer (ABC).\n\nPatients with HR+\u002FHER2+ ABC without prior systemic therapy for advanced disease are randomized in a 1:1:1 ratio into three arms, stratified by visceral metastasis status (yes vs. no) and metastatic type (de novo vs. recurrent).\n\nArm A: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive fulvestaciclib + HP + ET as maintenance therapy.\n\nArm B: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive HP + ET alone (without fulvestaciclib) as maintenance therapy.\n\nArm C (exploratory): Patients receive upfront fulvestaciclib + HP + ET as first-line therapy without induction chemotherapy (chemo-free).\n\nFor premenopausal\u002Fperimenopausal patients, ovarian function suppression (OFS) is added in all arms. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.\n\nThe primary endpoint is investigator-assessed progression-free survival (PFS) comparing Arm A versus Arm B. Secondary endpoints include PFS (Arm A vs. Arm C), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR), cumulative incidence of central nervous system (CNS) metastases, safety, and patient-reported outcomes (PROs).",[27,28,29,30],"Breast Cancer","HER2-positive Breast Cancer","Hormone Receptor-positive Breast Cancer","HR+\u002FHER2+ Breast Cancer","NOT_YET_RECRUITING","2026-07-20",{"date":34,"type":35},"2026-07-21","ACTUAL",{"date":37,"type":21},"2026-10-01",{"date":39,"type":21},"2032-12-31",{"name":41,"class":42},"Fudan University","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100647233","phase-2-targeting-aurora-a-kinase-to-overcome-treatment-resistance-in-advanced-hrher2-breast-cancer-100647233","NCT07706179","Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+\u002FHER2+ Breast Cancer","Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+\u002FHER2+ Breast Cancer: A Biomarker-Driven Pilot Clinical Trial","Inclusion Criteria:\n\n* Age \\> 18 years at the time of consent.\n* ECOG performance status \\\u003C\u002F=2 (Karnofsky \\>\u002F=60%).\n* Metastatic HR+\u002FHER2+ breast cancer (estrogen receptor (ER) and\u002For progesterone receptor (PR) ≥1%, HER2 3+ by immunohistochemistry (IHC) or amplified by in situ hybridization (ISH).\n* Prior standard induction treatment with chemotherapy + trastuzumab + pertuzumab (HP) or fam-trastuzumab deruxtecan (T-DXd) and have completed a minimum of 4 cycles without progressive disease.\n* Planned to start or are receiving endocrine therapy + HER2-directed (HP or pertuzumab\u002Ftrastuzumab\u002Fhyaluronidase-zzxf (PHESGO®)) therapy.\n* Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.\n* Left ventricular ejection fraction ≥ 50% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) documented within 6 weeks prior to the study treatment.\n* Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors volume 1.1 (RECIST 1.1) or evaluable disease with circulating tumor DNA (ctDNA) that is detectible. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n* Willingness to receive growth factor injections for neutropenia prophylaxis. Only patients without any grade 3 or higher neutropenia during induction chemotherapy or T-DXd will be permitted to proceed without prophylactic growth factor support. If the enrolled patients in this trial develop high grade or prolonged neutropenia, the addition of growth factor will be required.\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy.\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.\n* Treatment with any investigational drug within 14 days prior to registration, or within 5 half-lives of the investigational product, whichever is longer.",{"count":51,"type":21},10,[24],"The goal of this clinical trial is to learn if alisertib in addition to usual care works to treat HR+\u002FHER2+ breast cancer. The main questions it aims to answer are:\n\n* Does alisertib stop the communication between HR and HER2?\n* Are there genetic markers that predict how well someone's cancer will respond to alisertib?\n\nParticipants will receive alisertib in addition to their usual care.",[30,55],"Metastatic Breast Cancer","2026-07-09",{"date":58,"type":35},"2026-07-15",{"date":60,"type":21},"2026-08",{"date":62,"type":21},"2028-08",{"name":64,"class":42},"University of Wisconsin, Madison",1,"HR+\u002FHER2-breast Cancer"]