drugset / Trial / NCT01822314

Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer

NCT01822314 ↗

Phase 3 Completed 632 enrolled Fondazione Michelangelo
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions at surgery.

Timeline

Start
2013-04
Primary completion
2016-09
Completion
2023-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Abraxane Small molecule 125 mg/m2 —
Comparator Paclitaxel Small molecule 90 mg/m2 —