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

NCT01120561 | Unknown

• 1 other identifier: TDM4884g
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 15

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.

Conditions

Metastatic Breast Cancer

Keywords

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

Interventions

trastuzumab-MCC-DM1 DRUG

Intravenous repeating dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (15)

Investigational Site

Highland, California, 92346, United States

Location

Investigational Site

Stockton, California, 95204, United States

Location

Investigational Site

Denver, Colorado, 80220, United States

Location

Investigational Site

Plantation, Florida, 33324, United States

Location

Investigational Site

Lafayette, Indiana, 47905, United States

Location

Investigational Site

Cedar Rapids, Iowa, 52403, United States

Location

Investigational Site

Scarborough, Maine, 04074, United States

Location

Investigational Site

Baltimore, Maryland, 21231, United States

Location

Investigational Site

Detroit, Michigan, 48201, United States

Location

Investigational Site

Clarkson Valley, Missouri, 63011, United States

Location

Investigational Site

Farmington, New Mexico, 87401, United States

Location

Investigational Site

Charlotte, North Carolina, 28203, United States

Location

Investigational Site

Charleston, South Carolina, 29403, United States

Location

Investigational Site

Fairfax, Virginia, 22031, United States

Location

Investigational Site

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: May 1, 2010
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

US (15)