drugset / Trial / NCT01660542

An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer

NCT01660542

Phase 4 Completed 96 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.

Timeline

Start
2011-04
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Docetaxel Small molecule 100 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous