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Search / Trial NCT01120561

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

Launched by GENENTECH, INC. · May 7, 2010

Trial Information

Current as of May 13, 2025

No longer available

Keywords

Tdm 1 Eap T Dm1 Eap Tdm1 Eap Trastuzumab Mcc Dm1 Eap Trastuzumab Emtansine Eap T Pas

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Genentech, Inc.

Genentech, Inc. is a leading biotechnology company and a member of the Roche Group, dedicated to transforming the lives of patients with serious medical conditions through innovative therapies. Established in 1976, Genentech is recognized for its pioneering research in biologics and for developing groundbreaking treatments in areas such as oncology, immunology, and neuroscience. With a commitment to scientific excellence and patient-centered care, the company leverages cutting-edge technology and collaborative partnerships to advance drug discovery and development. Genentech's robust pipeline and focus on personalized medicine underscore its mission to address unmet medical needs and improve health outcomes globally.

Locations

Highland, California, United States

Stockton, California, United States

Denver, Colorado, United States

Plantation, Florida, United States

Lafayette, Indiana, United States

Cedar Rapids, Iowa, United States

Scarborough, Maine, United States

Baltimore, Maryland, United States

Detroit, Michigan, United States

Clarkson Valley, Missouri, United States

Farmington, New Mexico, United States

Charlotte, North Carolina, United States

Charleston, South Carolina, United States

Fairfax, Virginia, United States

Seattle, Washington, United States

Patients applied

0 patients applied

Trial Officials

Clinical Trials

Study Director

Genentech, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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