Finding studies
Finding studies
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Lead
GBG Forschungs GmbH
With
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
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted