Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Development of an active second-line treatment option for metastatic breast cancer patients
previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative
settings.
For each randomisation arm, 47 patients will be included. The trial was performed as a
2-stage phase II study according to the optimal design by Simon with overall response rate as
the primary objective.
Study Design:
Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks
Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks
Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks