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

Primary Purpose

Metastatic Triple Negative Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TPC
Bicalutamide 150 mg
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metastatic Triple Negative Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer Center
  • Sun Yat-sen University, Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TPC chemotherapy

Bicalutamide

Arm Description

Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)

Bicalutamide 150mg/day every 28 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

progression-free survival

Full Information

First Posted
January 9, 2017
Last Updated
January 26, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03055312
Brief Title
Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer
Acronym
SYSUCC-007
Official Title
A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Triple Negative Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPC chemotherapy
Arm Type
Active Comparator
Arm Description
Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)
Arm Title
Bicalutamide
Arm Type
Experimental
Arm Description
Bicalutamide 150mg/day every 28 days
Intervention Type
Drug
Intervention Name(s)
TPC
Other Intervention Name(s)
Chemotherapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bicalutamide 150 mg
Other Intervention Name(s)
Bicalutamide
Intervention Description
Bicalutamide 150mg/day,every 28 days
Primary Outcome Measure Information:
Title
Clinical benefit rate for 16 weeks
Description
The proportion of patients with complete response, partial response and stable disease
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-Yu Yuan, M.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Sun Yat-sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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