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A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

NCT00875979 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2013-12-24

Study results available
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Summary

This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.

Conditions

Interventions

DRUG

Trastuzumab emtansine [Kadcyla] 3.0 mg/kg

Trastuzumab emtansine was provided as a single-use lyophilized formulation.

DRUG

Trastuzumab emtansine [Kadcyla] 3.6 mg/kg

Trastuzumab emtansine was provided as a single-use lyophilized formulation.

DRUG

Pertuzumab 420 mg

Pertuzumab was provided as a single-use formulation.

Sponsors & Collaborators

Principal Investigators

  • Elaine K. Wong, M.Sc., M.D. · Genentech, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases
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 NCT00875979 on ClinicalTrials.gov