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Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer

NCT00868634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-08-31

No results posted yet for this study

Summary

The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.

Conditions

Interventions

DRUG

capecitabine

1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.

DRUG

bevacizumab

15 mg/kg i.v., day 1 Cycles are repeated every three weeks.

DRUG

capecitabine

1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.

DRUG

bevacizumab

15 mg/kg i.v., day 1. Cycles are repeated every three weeks.

DRUG

vinorelbine

25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.

Sponsors & Collaborators

  • Arbeitsgemeinschaft fur Internistische Onkologie

    collaborator OTHER

  • Arbeitskreis Klinische Studien

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • iOMEDICO AG

    lead INDUSTRY

Principal Investigators

  • Susanna Hegewisch-Becker, MD · Onkologische Schwerpunktpraxis Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2014-03-31
Completion
2015-10-31

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT00868634 on ClinicalTrials.gov