A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT01120561
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Interventions
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trastuzumab-MCC-DM1
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Investigational Site
Highland, California, United States
Investigational Site
Stockton, California, United States
Investigational Site
Denver, Colorado, United States
Investigational Site
Plantation, Florida, United States
Investigational Site
Lafayette, Indiana, United States
Investigational Site
Cedar Rapids, Iowa, United States
Investigational Site
Scarborough, Maine, United States
Investigational Site
Baltimore, Maryland, United States
Investigational Site
Detroit, Michigan, United States
Investigational Site
Clarkson Valley, Missouri, United States
Investigational Site
Farmington, New Mexico, United States
Investigational Site
Charlotte, North Carolina, United States
Investigational Site
Charleston, South Carolina, United States
Investigational Site
Fairfax, Virginia, United States
Investigational Site
Seattle, Washington, United States
Countries
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Other Identifiers
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TDM4884g
Identifier Type: -
Identifier Source: org_study_id
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