Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer (SYSUCC-007)

January 26, 2021 updated by: Zhong-yu Yuan, Sun Yat-sen University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University, Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TPC chemotherapy

Conventional chemotherapy(choose a):

TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)
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

Other Names:
  • Chemotherapy
Experimental: Bicalutamide
Bicalutamide 150mg/day every 28 days
Drug: Bicalutamide 150 mg
Bicalutamide 150mg/day,every 28 days
Other Names:
  • Bicalutamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefit rate for 16 weeks
Time Frame: 16 weeks
The proportion of patients with complete response, partial response and stable disease
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Zhong-Yu Yuan, M.D, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2016

Primary Completion (Actual)

November 15, 2020

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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