Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer

Phase 3

Terminated

• Conditions: Metastatic Triple Negative Breast Cancer
• Interventions: Drug: TPC; Drug: Bicalutamide 150 mg

• Registration Number: NCT03055312
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast

Detailed Description

This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).

Study Timeline

• Study Start: 2016-12-20
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Primary Completion: 2020-11-15
• Study Completion: 2020-11-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Age: 18-70 years old, female
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer
• For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
• Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
• After Recurrence has not received cancer treatment
• Life expectancy of at least 6 months
• Signed and dated an informed consent form

Exclusion Criteria

• ECOG score ≧2
• Only brain metastasis or meningeal metastasis
• Receiving other anti-tumor treatment
• Heart,lung,liver,kidney,bone marrow,and other functions badness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPC chemotherapy	TPC	Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)
Bicalutamide	Bicalutamide 150 mg	Bicalutamide 150mg/day every 28 days

Primary Outcome Measures

Name	Time	Method
Clinical benefit rate for 16 weeks	16 weeks	The proportion of patients with complete response, partial response and stable disease

Secondary Outcome Measures

Name	Time	Method
progression-free survival	24 months

Trial Locations

Locations (2)

Sun Yat-sen University, Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China