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



Status:Available
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:May 2010
Contact:Trial Information Support Line
Email:genentechclinicaltrials@druginfo.com
Phone:888-662-6728 (U.S. Only)

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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.


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.
We found this trial at
14
sites
Charlotte, North Carolina 28203
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Charlotte, NC
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Baltimore, MD
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Bettendorf, IA
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Charleston, South Carolina 29425
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Charleston, SC
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Detroit, MI
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Fairfax, VA
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Farmington, NM
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Fort Collins, CO
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Fort Myers, FL
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Indianapolis, IN
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Kansas City, MO
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San Francisco, California 94115
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San Francisco, CA
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Tacoma, WA
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York, ME
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