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

Xu fei

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Bicalutamide

Drug: Aromatase Inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT02910050

SYSU5010-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No 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