drugset / Trial / NCT01625429

Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer

NCT01625429 ↗

Phase 2 Unknown 30 enrolled Shanghai Cancer Hospital, China
NaSingle-groupOpen-labelTreatment

Summary

This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.

Timeline

Start
2012-06
Primary completion
2013-09
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — —
Subject Nab-paclitaxel Small molecule 125 mg/m2 —
Subject Trastuzumab Monoclonal antibody 2 mg/kg —

Indications