A Multicenter Randomized Phase III Study to Compare Capecitabine Alone or in Combination With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer and Progression After Previous Treatment With Trastuzumab
Trial design:
Prospective, multi-center, controlled, non blinded, randomized phase III Study
Treatment:
Patients with HER2 positive metastatic breast cancer and progression after previous
treatment with trastuzumab are being randomized to either:
A. Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * and discontinuation
of Trastuzumab
B. Capecitabine and Trastuzumab:
Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * Trastuzumab 6 mg/kg
body weight every 3 weeks i.v. as a 90 min infusion until progression *
Objectives:
Primary objective:
To compare the time to disease progression in patients with HER2 positive metastatic breast
cancer and progression after previous treatment with trastuzumab randomized to capecitabine
alone or in combination with trastuzumab.
Secondary objectives:
To compare the objective response rate between the two arms To compare the duration of
response To compare the clinical benefit defined as CR, PR, or stable disease > 24 weeks
between the two arms To evaluate the safety of the capecitabine + trastuzumab combination
To compare overall survival between the two arms
Tertiary objective:
To determine the HER2 status in tissue collected directly before study entry
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Any progression of disease or disease related death of a patient
Gunter von Minckwitz, Prof. Dr.
Principal Investigator
German Breast Group Forschungs GmbH
Germany: Paul-Ehrlich-Institut
GBG 26
NCT00148876
September 2003
January 2011
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