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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Terminated
CT.gov ID
NCT03055312
Collaborator
(none)
36
Enrollment
2
Locations
2
Arms
46.9
Actual Duration (Months)
18
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
Actual Study Start Date :
Dec 20, 2016
Actual Primary Completion Date :
Nov 15, 2020
Actual Study Completion Date :
Nov 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical benefit rate for 16 weeks [16 weeks]

      The proportion of patients with complete response, partial response and stable disease

    Secondary Outcome Measures

    1. progression-free survival [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060
    2 Sun Yat-sen University, Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03055312
    Other Study ID Numbers:
    • SYSUCC-007
    First Posted:
    Feb 16, 2017
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms
    Bicalutamide

    Study Results

    No Results Posted as of Jan 28, 2021