Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer

Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer

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 clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Inclusion Criteria:

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 Criteria:

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.