A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in First Line in Patients With Metastatic or Locally Advanced HER2-Positive Breast Cancer
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.
Clinical Trial Conditions: Breast Cancer
Treatments in this Clinical Trial : pertuzumab, trastuzumab [Herceptin], vinorelbine
Clinical Trial Phase: Phase 2
Eligible Clinical Trial Participant Age : Between 18 years to 100 years
Can Healthy Volunteers Participate: No
Clinical Trial Lead Sponsor: Hoffmann-La Roche
Detailed Clinical Trial Description: 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.
The clinical trial information was obtained from http://clinicaltrials.gov/ct2/show/NCT01565083
