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EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

NCT00448305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2012-01-05

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).

Conditions

  • Breast Neoplasms

Interventions

DRUG

EndoTAG-1 + paclitaxel

EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly

DRUG

EndoTAG-1

EndoTAG-1 44 mg/m² twice weekly

DRUG

Paclitaxel

Paclitaxel 90 mg/m² weekly

Sponsors & Collaborators

  • MediGene

    lead INDUSTRY

Principal Investigators

  • Ahmad Awada, Dr. · Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-02-28
Completion
2011-03-31

Countries

  • Belgium
  • France
  • India
  • Poland
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT00448305 on ClinicalTrials.gov