Chemotherapy with Enzalutamide or placebo in patients with androgen receptor positive, triple-negative metastatic breast cancer: A randomized phase II/III trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- Phase II Primary Outcome:
研究概览
简要总结
This is a multicentre randomized parallel group placebo controlled Phase II and Phase III clinical trial designed to evaluate the efficacy and safety of adding enzalutamide to standard chemotherapy in patients with androgen receptor positive triple negative locally advanced or metastatic breast cancer. Eligible patients aged eighteen years and above will be randomized in a one to one ratio to receive either enzalutamide with chemotherapy or placebo with chemotherapy. Chemotherapy will be selected by the treating physician from predefined standard regimens. The Phase II component will assess progression free survival and if efficacy criteria are met the study will continue to the Phase III component to assess overall survival. Secondary objectives include evaluation of overall response rate clinical benefit rate safety tolerability and quality of life. Treatment will continue until disease progression unacceptable toxicity or patient withdrawal with regular follow up for efficacy and survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must have histologically or cytologically confirmed invasive breast carcinoma.
- •Disease must be locally advanced unresectable or metastatic breast cancer.
- •Tumor must be triple negative breast cancer defined as estrogen receptor and progesterone receptor less than one percent by immunohistochemistry and HER2 negative defined as HER2 IHC 0 or 1 plus or IHC 2 plus with FISH negative.
- •Tumor must be androgen receptor positive defined as androgen receptor expression greater than or equal to ten percent by immunohistochemistry.
- •Subjects must be chemotherapy naive for the advanced or metastatic setting.
- •Subjects must have adequate hematologic hepatic renal and pulmonary function as defined in the protocol.
- •Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during treatment and for the protocol specified period after treatment.
- •Male subjects with partners of childbearing potential must agree to use effective contraception during treatment and for the protocol specified period after treatment.
- •Subjects must be able to understand and willing to provide written informed consent.
排除标准
- •Subjects receiving any other concurrent investigational agents are excluded.
- •Subjects previously exposed to anti androgen therapy after the diagnosis of breast cancer are excluded.
- •Subjects with active infection requiring systemic therapy are excluded.
- •Subjects with hepatitis B virus infection with positive surface antigen and elevated HBV DNA or hepatitis C virus infection with positive anti HCV antibody and elevated HCV RNA are excluded.
- •Subjects with known severe hypersensitivity to the investigational product or any component of its formulation are excluded.
- •Subjects with clinically significant active cardiovascular disease including unstable angina congestive heart failure New York Heart Association class two or higher serious uncontrolled cardiac arrhythmia or asymptomatic individuals with left ventricular ejection fraction less than fifty percent are excluded.
- •Subjects with other severe acute or chronic medical conditions including inflammatory bowel disease pneumonitis chronic kidney disease chronic liver disease pulmonary fibrosis known peripheral neuropathy greater than grade one as per CTCAE version five or significant psychiatric illness including recent or active suicidal ideation or behavior are excluded.
- •Pregnant women are excluded from the study.
- •Subjects with any other concomitant malignancy within the last five years except adequately treated basal cell carcinoma squamous cell carcinoma of the skin or carcinoma in situ of the cervix are excluded.
结局指标
主要结局
Phase II Primary Outcome:
时间窗: Baseline and every 3 months
Progression Free Survival defined as the time from the date of randomization to the date of documented disease progression as per RECIST version 1.1 or death from any cause whichever occurs first.
时间窗: Baseline and every 3 months
Phase III Primary Outcome:
时间窗: Baseline and every 3 months
Overall Survival defined as the time from the date of randomization to death from any cause or last follow up for surviving patients.
时间窗: Baseline and every 3 months
次要结局
- Overall Response Rate (ORR)(Clinical Benefit Rate (CBR))
研究者
Dr Sushmita Rath
Tata Memorial Hospital