Status:
COMPLETED
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Eli Lilly and Company
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the c...
Detailed Description
Upon determination of eligibility, all patients will be receive: Gemcitabine + Trastuzumab
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Her-2 positive metastatic breast cancer confirmed by biopsy
- Measurable disease
- Able to perform activities of daily living without considerable
- No previous chemotherapy with gemcitabine
- No more than one prior chemotherapy regimen for metastatic breast cancer
- Adequate bone marrow, liver and renal function
- Normal heart function
- Give written informed consent prior to entering this study.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Received previous treatment with gemcitabine
- History of brain metastases
- Serious underlying medical conditions
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00193063
Start Date
July 1 2001
End Date
August 1 2009
Last Update
March 12 2014
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