CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 152 enrolled
Drug / intervention
oral vinorelbine +5 moredrug
Likely dose
Gemcitabine 1250 mg/m²from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03887130
NCT03887130Phase 2Completed
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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

Pierre Fabre Medicament·interventional·Posted Mar 22, 2019·Updated Apr 30, 2024

In Brief

A Phase 2 clinical trial evaluating oral vinorelbine, Capecitabine, and 4 other interventions for Breast Cancer. Completed, enrolled 152 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2019
Enrollment StartMar 27, 2007
Primary CompletionApr 18, 2013
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 7.3 years ago

Interventions

oral vinorelbinedrug

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

Capecitabinedrug

Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14

Gemcitabine 1250 mg/m²drug

Gemcitabine 1250 mg/m² on day 1 \& day 8

Gemcitabine 1000 mg/m²drug

Gemcitabine: 1000 mg/m² on day 1 \& 8

Paclitaxeldrug

Paclitaxel 175 mg/m² on day 1

Docetaxeldrug

Docetaxel 75 mg/m² on day 1