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Oral Vinorelbine + Capecitabine vs Gemcitabine Combinations in mBC
NCT03887130Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Apr 2013
- Sponsor
- Pierre Fabre Laboratories
- Modality
- Small Molecules
- Drugs
- vinorelbine
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial of vinorelbine in breast cancer (3 arms), sponsored by Pierre Fabre Laboratories. Primary endpoint: Disease Control Rate at 6 years. Started Mar 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Vinorelbine-Capecitabine
Oral Vinorelbine + Capecitabine
Gemcitabine-Paclitaxel
Gemcitabine + Paclitaxel
Gemcitabine-Docetaxel
Gemcitabine + Docetaxel
03
Who it enrols
Patients with histologically confirmed HER2-negative metastatic breast cancer (adenocarcinoma) who have not received prior chemotherapy for metastatic disease. Patients must have a Karnofsky Performance Status >= 70%. Exclusion criteria include prior treatment with vinca-alkaloids, capecitabine, gemcitabine, or taxanes, and CNS involvement.
04
Endpoints
Primary
Disease Control Rate
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