NCT00191152

A Phase III Trial For Patients With Metastatic Breast Cancer

Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

Conditions

• Breast Cancer
• Breast Neoplasms
• Cancer of the Breast

Interventions

Type	Name	Description
DRUG	gemcitabine	1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
DRUG	docetaxel	75 mg/m2, intravenous (IV), every 21 days until disease progression
DRUG	capecitabine	1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

Timeline

• Start date: 2002-02-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2005-09-19
• Last updated: 2009-12-24
• Results posted: 2009-12-08

Locations

65 sites across 8 countries: United States, Argentina, Australia, Brazil, Mexico, Puerto Rico, South Korea, Taiwan