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