NCT00236899

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Metastatic Breast Cancer (MBC)

Interventions

Type	Name	Description
DRUG	Gemcitabine	Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
DRUG	Docetaxel	Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
DRUG	Paclitaxel	Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Timeline

• Start date: 2005-09-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2005-10-12
• Last updated: 2011-09-27
• Results posted: 2011-09-27

Locations

34 sites across 1 country: Italy