Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer
NCT ID: NCT03055312
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
36 participants
INTERVENTIONAL
2016-12-20
2020-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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TPC chemotherapy
Conventional chemotherapy(choose a):
TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)
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
Bicalutamide
Bicalutamide 150mg/day every 28 days
Bicalutamide 150 mg
Bicalutamide 150mg/day,every 28 days
Interventions
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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
Bicalutamide 150 mg
Bicalutamide 150mg/day,every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Only brain metastasis or meningeal metastasis
* Receiving other anti-tumor treatment
* Heart,lung,liver,kidney,bone marrow,and other functions badness
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Zhong-yu Yuan
Sun Yat-sen University Cancer Center
Principal Investigators
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Zhong-Yu Yuan, M.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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SYSUCC-007
Identifier Type: -
Identifier Source: org_study_id
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