drugset / Trial / NCT03304756

Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen

NCT03304756 ↗

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

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 50 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous