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

• ClinicalTrials.gov Identifier: NCT01120561
• Expanded Access Status: No longer available
• First Posted: May 11, 2010
• Last Update Posted: February 15, 2017
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Metastatic Breast Cancer	Drug: trastuzumab-MCC-DM1

Study Design

• Study Type: Expanded Access
• Official Title: An Expanded Access, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
• Study Start Date: May 2010

Interventions

Intervention Details:

• Drug: trastuzumab-MCC-DM1
  Intravenous repeating dose

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Investigational Site

Highland, California, United States, 92346

Investigational Site

Stockton, California, United States, 95204

United States, Colorado

Investigational Site

Denver, Colorado, United States, 80220

United States, Florida

Investigational Site

Plantation, Florida, United States, 33324

United States, Indiana

Investigational Site

Lafayette, Indiana, United States, 47905

United States, Iowa

Investigational Site

Cedar Rapids, Iowa, United States, 52403

United States, Maine

Investigational Site

Scarborough, Maine, United States, 04074

United States, Maryland

Investigational Site

Baltimore, Maryland, United States, 21231

United States, Michigan

Investigational Site

Detroit, Michigan, United States, 48201

United States, Missouri

Investigational Site

Clarkson Valley, Missouri, United States, 63011

United States, New Mexico

Investigational Site

Farmington, New Mexico, United States, 87401

United States, North Carolina

Investigational Site

Charlotte, North Carolina, United States, 28203

United States, South Carolina

Investigational Site

Charleston, South Carolina, United States, 29403

United States, Virginia

Investigational Site

Fairfax, Virginia, United States, 22031

United States, Washington

Investigational Site

Seattle, Washington, United States, 98109

Sponsors and Collaborators

Genentech, Inc.

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01120561
• Other Study ID Numbers: TDM4884g
• First Posted: May 11, 2010
• Last Update Posted: February 15, 2017
• Last Verified: February 2017

Keywords provided by Genentech, Inc.:

TDM-1 EAP; T-DM1 EAP; TDM1 EAP; Trastuzumab-MCC-DM1 EAP; Trastuzumab emtansine; EAP; T-PAS

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Trastuzumab; Ado-Trastuzumab Emtansine; Antineoplastic Agents, Immunological; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action