The Trial Comparing Dose-dense AC-T With TP as Adjuvant Therapy for TNBC With Homologous Recombination Repair Deficiency
NCT03876886 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2019-03-21
Summary
The purpose of this trial is to compare the 3-year disease-free survival of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer with homologous recombination repair deficiency.
The other purpose of this trial is to observe the patient's tolerance.
Conditions
Interventions
- DRUG
-
Epirubicin
Epirubicin 90mg/m2 iv d1 or divide into two days
- DRUG
-
cyclophosphamide600mg/m2 iv d1,q14d\*4cycles;with G-CSF support: 3ug/kg ih
- DRUG
-
paclitaxel 175mg/m2 iv d1, q14d\*4cycles
- DRUG
-
carboplatin AUC=3 iv d2, q14d\*8cycles;with G-CSF support: 3ug/kg ih
- DRUG
-
paclitaxel 175mg/m2 iv d1, q14d\*8cycles
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-22
- Primary Completion
- 2024-02-29
- Completion
- 2024-12-31
Countries
- China
Study Locations
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