CTIS2024-513284-30-00进行中（未招募）1 期
A Phase 1b Trial of ARV-471 in Combination with Everolimus in Patients with ER+, HER2– Advanced or Metastatic Breast Cancer - ARV-471-mBC-102
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients must be = 18 years., Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer (metastatic, recurrent, or unresectable). • ER+ disease must be documented by IHC according to the ASCO/CAP Guidelines • HER2- disease must be documented by either IHC or in situ hybridization per ASCO/CAP guidelines, Women must meet definitions below for one of the following categories: Postmenopausal women must have at least 1 of the following: prior bilateral oophorectomy, age = 60 years, or age < 60 years and amenorrheic for at least 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH/estradiol in the postmenopausal range • Pre- and peri-menopausal women must be on ovarian suppression with a GnRH agonist for at least 4 weeks prior to initiation of study treatment and for 8 weeks after the last dose of study treatment., Patients must have measurable disease or non-measurable (evaluable) disease, per RECIST 1.1., ECOG (Eastern Cooperative Group) performance status of 0 or 1., Patients must have received a minimum of 1 and up to 3 lines of anticancer therapy in the advanced/metastatic setting: • Patients must have received and progressed on (or were intolerant to) a CDK 4/6 inhibitor, either alone or in combination • Patients must have received at least 1 endocrine therapy, either alone or in combination • Patients may have received up to 1 line of chemotherapy, Must be willing and capable of taking oral medication without crushing, dissolving, or chewing tablets/capsules.
排除标准
- •Untreated brain metastases or brain metastases requiring steroids above physiologic replacement doses, Any of the following in the previous 12 months: • Myocardial infarction • Severe/unstable angina • Coronary/peripheral artery bypass graft • Symptomatic (NYHA class III or IV) congestive heart failure • Cerebrovascular accident (CVA) • Transient ischemic attack (TIA) • Symptomatic pulmonary embolism • Other clinically significant episode of thromboembolism, Any of the following in the previous 6 months: • Congenital long QT syndrome • Torsade de Pointes, • Sustained ventricular tachyarrhythmia and ventricular fibrillation • Left anterior hemiblock (bifascicular block) • Ongoing cardiac arrythmias/dysrhythmias of NCI CTCAE Grade =2 • Atrial fibrillation of any grade (Grade =2 in the case of asymptomatic lone atrial fibrillation), Patients with a known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung function., Prior treatment with ARV-471., Prior treatment(s) (including investigational treatments) targeting mTOR (e. g. everolimus)., Prior anticancer or investigational drug treatment within the following windows: • Fulvestrant treatment < 28 days before C1D1 • Tamoxifen or AI < 14 days before C1D1 • CDK 4/6 treatment < 14 days before C1D1, Any prior anticancer or investigational anticancer drug therapy < 28 days or five half-lives (whichever is shorter) before C1D1 (except as mentioned in exclusion criteria above)., Any live vaccines within 14 days of C1D1.
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