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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01120561
First received: May 7, 2010
Last updated: May 9, 2013
Last verified: May 2013

May 7, 2010
May 9, 2013
May 2010
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Complete list of historical versions of study NCT01120561 on ClinicalTrials.gov Archive Site
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A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
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.

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Expanded Access
Phase 2
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Metastatic Breast Cancer
Drug: trastuzumab-MCC-DM1
Intravenous repeating dose
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01120561
TDM4884g
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Genentech
Genentech
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Study Director: Clinical Trials Genentech
Genentech
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP