Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

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 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.

Detailed description:
Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Arms:
arm 1: All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.

Interventions: intervention 1: Trastuzumab intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Trastuzumab intervention 2: Gemcitabine

Protocol document: