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

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Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01120561
First received: May 7, 2010
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: trastuzumab-MCC-DM1
Phase 2

Study Type: Expanded Access     What is 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Study Start Date: May 2010
Intervention Details:
    Drug: trastuzumab-MCC-DM1
    Intravenous repeating dose
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120561

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01120561     History of Changes
Other Study ID Numbers: TDM4884g
Study First Received: May 7, 2010
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

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
Maytansine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 19, 2014