NCT00781612

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel will be administered as per local prescribing information.
DRUG	Paclitaxel	Paclitaxel will be administered as per local prescribing information.
DRUG	Pertuzumab	Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
DRUG	Trastuzumab	Trastuzumab will be administered as per local prescribing information.
DRUG	Trastuzumab Emtansine	Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
DRUG	Atezolizumab	Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

Timeline

• Start date: 2008-10-16
• Primary completion: 2029-09-30
• Completion: 2030-04-30
• First posted: 2008-10-29
• Last updated: 2025-12-24

Locations

178 sites across 35 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, New Zealand, North Macedonia, Norway, Panama, Peru, Philippines, Poland, Portugal, Russia, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom