A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer

February 13, 2017 updated by: Genentech, Inc.

An Expanded Access, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer

This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Highland, California, United States, 92346
        • Investigational Site
      • Stockton, California, United States, 95204
        • Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Investigational Site
    • Florida
      • Plantation, Florida, United States, 33324
        • Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Investigational Site
    • Missouri
      • Clarkson Valley, Missouri, United States, 63011
        • Investigational Site
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Investigational Site
    • Washington
      • Seattle, Washington, United States, 98109
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically documented breast cancer
  • Locally advanced or metastatic breast cancer
  • HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment
  • Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or metastatic breast cancer
  • Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: a taxane, alone or in combination with another agent, and Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting
  • Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer during their most recent treatment regimen
  • Progression must occur during or after most recent treatment for locally advanced/metastatic breast cancer or within 6 months after completing adjuvant therapy
  • Adequate hematologic and end organ function
  • Agreement to use an effective form of birth control throughout the study
  • Life expectancy ≥ 90 days as assessed by the investigator

Exclusion Criteria:

  • Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy
  • Prior T-DM1 therapy
  • History of exposure to cumulative doses of select anthracyclines
  • History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued
  • Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment
  • Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment
  • History of clinically significant cardiac dysfunction
  • Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
  • Current severe, uncontrolled systemic disease
  • Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment
  • Pregnancy or lactation

NOTE: The site selection process has been completed. Patients can enroll at participating sites.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (ESTIMATE)

May 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDM4884g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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