Overview

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.