A Multicenter Phase II Study to Determine the Efficacy of Capecitabine as First Line Monochemotherapy in Patients With HER2 Negative, Medium-risk, Metastatic Breast Cancer
Study design:
Prospective, open phase II trial
Treatment:
Capecitabine 2000 mg/m² orally day 1-14 q day 22 until progression, unacceptable toxicity,
patient's request or withdrawal from study
Primary objective
To determine the time to disease progression in patients with HER2 negative metastatic
breast cancer after 1st line monochemotherapy with capecitabine
Secondary objectives
1. To determine the objective response rate
2. To determine the duration of response
3. To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks
4. To evaluate the safety and toxicity of capecitabine
5. To assess quality of life within 1 year after start of capecitabine treatment
6. To determine overall survival
7. To determine the objective response rate in male patients
8. To evaluate QoL the modified Brunner Score (Appendix 7 )
Tertiary objective
To determine the DPD and Proteomics in serum
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Any progression of disease or disease related death of a patient
No
Manfred Kaufmann, MD
Principal Investigator
Klinikum der J. W. Goethe Universität, Universitätsfrauenklinik
Germany: Federal Institute for Drugs and Medical Devices
GBG 39
NCT00196820
July 2005
December 2008
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