Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC

A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules

Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).

Inclusion Criteria:

• Histologic diagnosis of metastatic breast cancer (MBC).
• Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
• Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
• Patients with measurable disease.
• Previous hormonal therapy for adjuvant setting or metastatic disease.

Exclusion Criteria:

• Previous chemotherapy for MBC
• Previous chemotherapy with gemcitabine in any setting of disease
• Patient candidable to treatment with trastuzumab.