A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 118
- 试验地点
- 70
- 主要终点
- Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population
研究概览
简要总结
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at least 18 years of age;
- •Advanced AR+ TNBC;
- •Availability of a representative tumor specimen:
- •Either measurable disease or bone only nonmeasurable disease;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Any severe concurrent disease, infection, or comorbid condition;
- •Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data;
- •Current or previously treated brain metastasis or active leptomeningeal disease;
- •Current hormone replacement therapy;
- •Local palliative radiation therapy within 7 days before day 1;
- •History of another invasive cancer within 5 years of day 1;
- •Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit;
- •Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;
- •History of seizure or any condition that may predispose to seizure;
- •Clinically significant cardiovascular disease;
- •Active gastrointestinal disorder affecting absorption;
- •Major surgery within 4 weeks before day 1;
- •Treatment with any commercially available anticancer agent within 14 days before day 1;
- •Treatment with any investigational agent within 2 weeks before day 1;
- •Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
- •Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
- •Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
研究组 & 干预措施
Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population
时间窗: Week 16
Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for \>=16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size \<10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population
时间窗: Week 16
Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for \>= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size \<10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
次要结局
- Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population(Week 24)
- Percentage of Participants With Clinical Benefit at Week 24: ITT Population(Week 24)
- Percentage of Participants With Best Objective Response: Evaluable Population(From Baseline up to disease progression or death due to any cause (up to 87 Weeks))
- Percentage of Participants With Best Objective Response: ITT Population(From Baseline up to disease progression or death due to any cause (up to 87 Weeks))
- Progression-Free Survival (PFS): Evaluable Population(From Baseline up to disease progression or death due to any cause (up to 87 Weeks))
- Progression-Free Survival: ITT Population(From Baseline up to disease progression or death due to any cause (up to 87 Weeks))
- Time to Response: Evaluable Population(From first dose of study drug until first documentation of CR or PR or data censoring date, whichever occurred first (up to 87 Weeks))
- Duration of Response: Evaluable Population(From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (up to 87 Weeks))
- Number of Participants With Postbaseline Laboratory Toxicities Grade 3 or 4(From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years))