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

Summary

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

Timeline

Start

2005-09

Primary completion

2010-08

Completion

2010-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Treatment Schedule (Weekly) vs Treatment Schedule (3 Weekly); p = 0.345; Hazard Ratio (HR) 1.14 (95% CI 0.87 to 1.50); Regression, Cox NCT00236899 ↗

registry analysis (superiority or other test); Treatment Drug (Docetaxel) vs Treatment Drug (Paclitaxel); p = 0.150; Hazard Ratio (HR) 1.23 (95% CI 0.93 to 1.62); Regression, Cox NCT00236899 ↗

Publications

• Del Mastro L, Fabi A, Mansutti M, De Laurentiis M, Durando A, Merlo DF, Bruzzi P, La Torre I, Ceccarelli M, Kazeem G, Marchi P, Boy D, Venturini M, De Placido S, Cognetti F. Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments. BMC Cancer. 2013 Mar 28;13:164. doi: 10.1186/1471-2407-13-164.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	30 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1250 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	175 mg/m2	Intravenous

Indications