Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

This study has been terminated.
(The number of inclusion was reached normally)
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT01069796
First received: February 16, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Triple Negative Metastatic Breast Cancer
Drug: Paclitaxel
Drug: Bevacizumab
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • objective response rate [ Time Frame: 36 months for recrutment and 30 months for follow up ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069796

Locations
France
Centre Paul Papin
Angers, France
Clinique Tivoli
Bordeaux, France
Centre Hospitalier William Morey
Chalon sur Saône, France
Centre Hospitalier Intercommunal
Fréjus, France
Clinique des 4 Pavillons
Lormont, France
Hôpital Privé Clairval
Marseille, France
Centre Azuréen de Cancérologie
Mougins, France
Centre Alexis Vautrin
Nancy, France
Centre Antoine Lacassagne
Nice, France
Centre Hospitalier Régional
Orléans, France
Institut Jean Godinot
Reims, France
Hôpitaux Drôme Nord - Site de Romans-sur-Isère
Romans sur Isère, France
Centre Henri Becquerel
Rouen, France
Clinique Armoricaine de Radiologie
Saint Brieuc, France
Clinique de l'Union
St Jean, France
Centre Paul Strauss
Strasbourg, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
  More Information

No publications provided

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01069796     History of Changes
Other Study ID Numbers: A-Taxel (GINECO BR108)
Study First Received: February 16, 2010
Last Updated: January 9, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: CPP

Keywords provided by ARCAGY/ GINECO GROUP:
triple negative
metastatic
breast cancer
First line chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Capecitabine
Bevacizumab
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014