Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Docetaxel; Gemcitabine; Paclitaxel; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the breast;

• Documented metastatic disease previously untreated by chemotherapy;

• HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;

• Karnofsky Performance Status 70%.

Exclusion Criteria:

• Local relapse alone after conservative treatment or contra-lateral tumor;

• Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;

• Concomitant hormonal therapy for metastatic breast cancer;

• Prior chemotherapy in the metastatic setting;

• Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;

• Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.