Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT)
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Primary objectives :
1. To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and
lapatinib (Tykerb®) (PGT) as preoperative chemotherapy in patients with HER2 positive
operable breast cancer
Secondary objectives :
1. To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT
2. To determine the safety profile
3. To assess pCR in primary tumor and axillary LN
4. To evaluate clinical response rate, disease free survival (DFS), and overall survival
(OS)
5. To assess breast conserving rate after preoperative PGT
Phase:
Phase 1
Details
Lead Sponsor:
Jungsil Ro
Collaborators:
CJ HealthCare Corporation GlaxoSmithKline HK inno.N Corporation