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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Gemcitabine; Paclitaxel

Criteria

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.