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Neoadjuvant Carboplatin/Paclitaxel Followed by Dose-Dense Doxorubicin/Cyclophosphamide in Triple-Negative Breast Cancer
NCT03301350Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2017
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- University of Wisconsin–Madison
- Modality
- DNA Intercalators/Alkylators
- Conditions
- triple-negative breast cancer (TNBC)
01
Overview
Phase 2, open-label, single-arm trial of carboplatin, paclitaxel, doxorubicin and cyclophosphamide in triple-negative breast cancer (TNBC), sponsored by University of Wisconsin–Madison. Primary endpoint: Pathologic Complete Response Rate up to 2 years. Started Nov 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Neoadjuvant Chemotherapy
Sequential neoadjuvant chemotherapy followed by surgery
03
Who it enrols
Adults under 75 with ER/PR/HER2-negative invasive breast cancer, clinical tumor size >= 2.1 cm or node-positive, ECOG PS 0, adequate organ function, no prior chemo/radiation within 6 months.
04
Endpoints
Primary
Pathologic Complete Response Rate
Secondary
Number of Cycles of Chemotherapy Administered
Total Dose of Chemotherapy Administered
Delays of Administered Chemotherapy
Number of Treatment-related Toxicities Experienced by Participants
Recurrence-free Survival
Overall Survival
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