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

NCT03887130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2024-04-30

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-27
Primary Completion
2013-04-18
Completion
2013-04-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887130 on ClinicalTrials.gov