Clinical trial · Interventional
Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer
A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
NCT03055312CI-TRIAL-00049696SYSUCC-007terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide 150 mg | Drug | Bicalutamide | ALIAS |
| TPC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TPC chemotherapy
- description
- Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)
- interventionNames
- Drug: TPC
- type
- EXPERIMENTAL
- label
- Bicalutamide
- description
- Bicalutamide 150mg/day every 28 days
- interventionNames
- Drug: Bicalutamide 150 mg
Primary outcomes (1)
- measure
- Clinical benefit rate for 16 weeks
- timeFrame
- 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.