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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

NCT00781612 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2025-12-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-16
Primary Completion
2029-09-30
Completion
2030-04-30

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781612 on ClinicalTrials.gov