A Phase 2 interventional study of Bicalutamide and Aromatase Inhibitor in Breast Cancer, sponsored by Xu fei. Status unknown at 1 site in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by Xu fei · Phase 2, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 58 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Xu fei as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
Drug: Bicalutamide · Drug: Aromatase Inhibitor
50mg once a day orally
Also known as: Casodex
participants will receive any kind of aromatase inhibitor which has not been received before (steroidal AI change to nonsteroidal AI and vice versa), Letrozole 2.5mg once a day orally, Anastrozole 1mg once a day orally, Exemestane 25mg once a day orally
Also known as: letrozole, anastrozole, exemestane
clinical benefit rate（CBR）
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.
Time frame: 24 weeks
progression free survival
Time from to the first documentation of objective tumor progression or to death due to any cause.
Time frame: baseline up to approximately 6 months
objective response rate of bicalutamide plus another AI in participants with measurable disease
objective response rate includes complete response, partial response.
Time frame: 24 weeks
tolerability of bicalutamide plus an Aromatase inhibitor
evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .
Time frame: 2 years
Plan to share: No
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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