A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- clinical benefit rate（CBR）
研究概览
简要总结
This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor.
详细描述
Androgen receptor(AR) is closely related to molecular type, treatment and prognosis in breast cancer. Over 70% of breast cancer expressed androgen receptor. And in some estrogen receptor positive breast cancer cells which are resistant to Aromatase inhibitors can change androgen receptor dependent. So AR may be a new target in the treatment of breast cancer. Bicalutamide is a selective androgen receptor inhibitor with a clinical benefit rate of 19% and median progression free survival of 12 weeks in the ER-/AR+ metastatic breast cancer. This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER+/AR+/HER- metastatic breast cancer patients who have disease progression after treatment of an AI.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
- •Metastatic or unresectable locally advanced disease
- •Age over 18 years
- •Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available）
- •Patient must have disease progression after treatment of an Aromatase inhibitor.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2
- •Life expectancy over 3 months.
- •Measurable disease according to RECIST version 1.1 or only bone metastasis
- •Adequate hematological, hepatic function.
- •Voluntarily signed and dated written informed consent prior to any study specific procedure.
排除标准
- •Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
- •Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
- •History of other primary malignancy
- •Resistant to steroidal or nonsteroidal aromatase Inhibitor
研究组 & 干预措施
bicalutamide+ Aromatase Inhibitor
ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
干预措施: Bicalutamide (Drug)
bicalutamide+ Aromatase Inhibitor
ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
干预措施: Aromatase Inhibitor (Drug)
结局指标
主要结局
clinical benefit rate（CBR）
时间窗: 24 weeks
Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 2 months for the first 6 months and then every 3 months till progression or termination of the study.CBR is defined as ratio of participants who have stable disease for over 24 weeks.
次要结局
- tolerability of bicalutamide plus an Aromatase inhibitor(2 years)
- objective response rate of bicalutamide plus another AI in participants with measurable disease(24 weeks)
- progression free survival(baseline up to approximately 6 months)
研究者
Xu fei
associate chief physician,associate professor,MD
Sun Yat-sen University