NCT03887130

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

Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	oral vinorelbine	Oral vinorelbine 60 mg/m² on day 1 \& day 8, for cycle 1, and then 80 mg/m² on day 1 \& day 8, every 3 weeks for subsequent cycles
DRUG	Capecitabine	Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
DRUG	Gemcitabine 1250 mg/m²	Gemcitabine 1250 mg/m² on day 1 \& day 8
DRUG	Gemcitabine 1000 mg/m²	Gemcitabine: 1000 mg/m² on day 1 \& 8
DRUG	Paclitaxel	Paclitaxel 175 mg/m² on day 1
DRUG	Docetaxel	Docetaxel 75 mg/m² on day 1

Timeline

• Start date: 2007-03-27
• Primary completion: 2013-04-18
• Completion: 2013-04-18
• First posted: 2019-03-22
• Last updated: 2024-04-30
• Results posted: 2024-04-30