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XeNa: Metronomic vs Standard Vinorelbine plus Capecitabine in Metastatic Breast Cancer
NCT01941771Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2012
- Primary completion
- Jan 2015
- Countries
- 1
- Sponsor
- Aarhus University
- Modality
- Small Molecules
- Drugs
- vinorelbine
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial of vinorelbine in breast cancer (2 arms), sponsored by Aarhus University. Primary endpoint: Overall Response Rate at 60 months. Started Jun 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard Schedule
Vinorelbine D1,8 + Capecitabine D1-14
Metronomic Schedule
Vinorelbine 3x weekly + Capecitabine D1-14
03
Who it enrols
Patients with locally advanced or metastatic HER2-negative breast cancer, WHO performance status < 3, and no brain metastases. Excludes patients with prior Capecitabine or Vinorelbine treatment or more than one line of chemotherapy for metastatic disease.
04
Endpoints
Primary
Overall Response Rate
Secondary
Time to Progression
Overall Survival
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