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Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer

NCT01941771 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2016-10-28

No results posted yet for this study

Summary

The study hypothesis is that metronomic treatment is more efficient than standard treatment.

Conditions

Interventions

DRUG

Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

DRUG

Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.

Sponsors & Collaborators

  • Pierre Fabre Laboratories

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Sven Tyge Langkjer, MD, PhD · University hospital of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-01-31
Completion
2015-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT01941771 on ClinicalTrials.gov