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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01120561
• Other study ID #: TDM4884g
• Status: No longer available
• Phase: N/A
• First received: May 7, 2010
• Last updated: February 13, 2017
• Start date: May 2010

Study information

• Verified date: February 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• trastuzumab-MCC-DM1
Intravenous repeating dose

Locations

Country	Name	City	State
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Cedar Rapids	Iowa
United States	Investigational Site	Charleston	South Carolina
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Clarkson Valley	Missouri
United States	Investigational Site	Denver	Colorado
United States	Investigational Site	Detroit	Michigan
United States	Investigational Site	Fairfax	Virginia
United States	Investigational Site	Farmington	New Mexico
United States	Investigational Site	Highland	California
United States	Investigational Site	Lafayette	Indiana
United States	Investigational Site	Plantation	Florida
United States	Investigational Site	Scarborough	Maine
United States	Investigational Site	Seattle	Washington
United States	Investigational Site	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States,