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A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

NCT00509769 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2013-04-02

Study results available
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Summary

This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Conditions

Interventions

DRUG

Trastuzumab emtansine [Kadcyla]

Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Holden, M.D. · Genentech, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-01-31
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00509769 on ClinicalTrials.gov