Phase Ib/II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Sunitinib
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
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
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Jungsil Ro
Collaborators:
CJ HealthCare Corporation HK inno.N Corporation Pfizer