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

NCT03055312 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-01-28

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Zhong-Yu Yuan, M.D · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2020-11-15
Completion
2020-11-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055312 on ClinicalTrials.gov