NCT03055312

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

A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	TPC	Conventional chemotherapy(choose a): TX:(Docetaxel 75mg/m2 iv day1 and Capecitabine 950mg/m2 po twice daily days 1-14)every 3 weeks. GT:(Paclitaxel 175mg/m2 iv day1 and Gemcitabine 1250mg/m2 iv days 1 \& days 8)every 3 weeks. GC:(Gemcitabine 1000mg/m2 on days 1 \& days 8 and Carboplatin by Area Under Curve (AUC) 2 iv on days 1 \& days 8) every 3 weeks
DRUG	Bicalutamide 150 mg	Bicalutamide 150mg/day,every 28 days

Timeline

• Start date: 2016-12-20
• Primary completion: 2020-11-15
• Completion: 2020-11-15
• First posted: 2017-02-16
• Last updated: 2021-01-28

Locations

2 sites across 1 country: China