drugset / Trial / NCT03304756
Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen
Phase 2
Completed
41 enrolled
Brazilian National Cancer Institute
Dana-Farber Cancer Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days was further provided for 4 cycles. Primary outcome was pathological complete response in the breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and overall survival.
Timeline
- Start
- 2007-12-15
- Primary completion
- 2012-04-15
- Completion
- 2014-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |