- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055312
Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer (SYSUCC-007)
A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University, Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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) |
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:
|
Experimental: Bicalutamide
Bicalutamide 150mg/day every 28 days
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Bicalutamide 150mg/day,every 28 days
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Zhong-Yu Yuan, M.D, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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