A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer

Phase 2 Completed 213 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.

Timeline

Start: 2012-04
Primary completion: 2015-10
Completion: 2015-10

Publications

Perez EA, Lopez-Vega JM, Petit T, Zamagni C, Easton V, Kamber J, Restuccia E, Andersson M. Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results. Breast Cancer Res. 2016 Dec 13;18(1):126. doi: 10.1186/s13058-016-0773-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Vinorelbine	Small molecule	30 mg/m2	Intravenous
Subject	Vinorelbine	Small molecule	35 mg/m2	Intravenous

A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer

Summary

Timeline

Publications

Drugs

Indications