Overview

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

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xu fei
Collaborator:
Sun Yat-sen University
Treatments:
Anastrozole
Androgens
Aromatase Inhibitors
Bicalutamide
Exemestane
Letrozole
Criteria
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