Phase Ib/II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Sunitinib

Summary

Phase Ib part: ▪ Primary objective: To demonstrate the recommended dose of the combination of paclitaxel, gemcitabine, and sunitinib (sutene®) (PGS) as preoperative chemotherapy in patients with HER2-negative operable breast cancer * Secondary objective: 1. To demonstrate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of this regimen 2. To determine the safety profile Phase II part * Primary objective: To evaluate the pathologic complete response rate (pCR) to preoperative administration of PGS ▪ Secondary objective: 1. To assess breast conserving rate after preoperative PGS 2. To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) 3. To assess the safety profiles of PGS

Timeline

Start

2009-03

Primary completion

2009-12

Completion

2010-11

Drugs

Indications