A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00191373
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 12, 2007
Information provided by:
Eli Lilly and Company

September 12, 2005
September 19, 2005
September 12, 2007
March 2002
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- Overall response rates
Same as current
Complete list of historical versions of study NCT00191373 on Archive Site
Time to disease progression,Time to treatment failure, Overall survival, Toxicity of the combination
  • - Time to disease progression
  • - Time to treatment failure
  • - Overall survival
  • - Toxicity of the combination
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A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
Phase II Study of Gemcitabine and Trastuzumab Therapy in Patients With HER2 Overexpressing Metastatic Breast Cancer
This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Cancer of the Breast
  • Breast Cancer
  • Drug: Gemcitabine
  • Drug: Trastuzumab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2007
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Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease
  • Tumors tested by IHC must be 3+ positive for HER2 overexpression. Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2. Tumors that are 3+ by IHC but negative by FISH assay are ineligible
  • Patients must have measurable disease
  • Patients may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer.
  • Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. Patients may NOT have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months.

Exclusion Criteria:

  • Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval
  • Patients with known leptomeningeal carcinomatosis
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Eli Lilly and Company
Not Provided
Study Director: CALL 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2007

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