Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer
- Registration Number
- NCT02910050
- Lead Sponsor
- Xu fei
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 58
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description bicalutamide+ Aromatase Inhibitor Aromatase Inhibitor ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor bicalutamide+ Aromatase Inhibitor Bicalutamide ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
- Primary Outcome Measures
Name Time Method clinical benefit rate（CBR） 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.
- Secondary Outcome Measures
Name Time Method tolerability of bicalutamide plus an Aromatase inhibitor 2 years evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .
objective response rate of bicalutamide plus another AI in participants with measurable disease 24 weeks objective response rate includes complete response, partial response.
progression free survival baseline up to approximately 6 months Time from to the first documentation of objective tumor progression or to death due to any cause.
Trial Locations
- Locations (1)
State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China