BETTER: Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer

Sponsor

Xu fei (Other)

Overall Status

Unknown status

CT.gov ID

NCT02910050

Collaborator

Sun Yat-sen University (Other)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Bicalutamide Drug: Aromatase Inhibitor	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bicalutamide+ Aromatase Inhibitor ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor	Drug: Bicalutamide 50mg once a day orally Other Names: Casodex Drug: Aromatase Inhibitor 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 Other Names: letrozole anastrozole exemestane

Arm

Intervention/Treatment

Experimental: bicalutamide+ Aromatase Inhibitor

ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor

Drug: Bicalutamide

50mg once a day orally

Other Names:

Casodex

Drug: Aromatase Inhibitor

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

Other Names:

letrozole

anastrozole

exemestane

Outcome Measures

Primary Outcome Measures

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

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.
objective response rate of bicalutamide plus another AI in participants with measurable disease [24 weeks]
objective response rate includes complete response, partial response.
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) .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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