Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

March 15, 2016 updated by: ARCAGY/ GINECO GROUP

A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer

Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Centre Paul Papin
      • Bordeaux, France
        • Clinique Tivoli
      • Chalon sur Saône, France
        • Centre Hospitalier William Morey
      • Fréjus, France
        • Centre Hospitalier Intercommunal
      • Lormont, France
        • Clinique des 4 Pavillons
      • Marseille, France
        • Hopital Prive Clairval
      • Mougins, France
        • Centre Azuréen de Cancérologie
      • Nancy, France
        • Centre Alexis Vautrin
      • Nice, France
        • Centre Antoine Lacassagne
      • Orléans, France
        • Centre Hospitalier Regional
      • Reims, France
        • Institut Jean Godinot
      • Romans sur Isère, France
        • Hôpitaux Drôme Nord - Site de Romans-sur-Isère
      • Rouen, France
        • Centre Henri Becquerel
      • Saint Brieuc, France
        • Clinique Armoricaine de Radiologie
      • St Jean, France
        • Clinique de l'Union
      • Strasbourg, France
        • Centre Paul Strauss
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease
  • Measurable disease
  • Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry

Exclusion Criteria:

  • Prior chemotherapy for metastatic disease
  • HER2 positive and/or hormonal receptor positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Association bevacizumab paclitaxel capecitabine breast cancer
  • bevacizumab 10 mg/kg in IV, D1 and D15
  • paclitaxel 80mg/m2 in IV, D1 to D8 and D15
  • capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3
Drug: Paclitaxel
80 mg/m² weekly
Drug: Bevacizumab
10 mg/kg d1 d15
Drug: Capecitabine
800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 & 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: 36 months for recrutment and 30 months for follow up
36 months for recrutment and 30 months for follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-Taxel (GINECO BR108)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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