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-   -   A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in (http://her2support.org/vbulletin/showthread.php?t=59094)

'lizbeth 09-23-2013 12:01 PM

A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in
 
Phase II with 80 locations

This two-cohort, open-label, multicenter, phase II study will assess the safety and efficacy of pertuzumab given in combination with Herceptin (trastuzumab) and vinorelbine in first line in patients with metastatic or locally advanced HER2-positive breast cancer. Patients will receive pertuzumab 840 mg and Herceptin 8 mg/kg administered sequentially as separate iv infusions on Day 1 of Cycle 1. From Cycle 2 onwards, patients will receive pertuzumab 420 mg and Herceptin 6 mg/kg, administered either sequentially as separate iv infusions (Cohort 1) or together in one infusion bag (Cohort 2) every 3 weeks. Vinorelbine will be administered at 25 mg/m2 iv on Days 1 and 8 of Cycle 1, and at 30-35 mg/m2 on Days 1 and 8 of each following 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, or withdrawal of consent or death.

http://www.clinicaltrials.gov/ct2/sh...o_unk=Y&rank=5


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