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Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01069796
Recruitment Status : Terminated (The number of inclusion was reached normally)
First Posted : February 17, 2010
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Triple Negative Metastatic Breast Cancer Drug: Paclitaxel Drug: Bevacizumab Drug: Capecitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2010
Primary Completion Date : March 2012
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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

Primary Outcome Measures :
  1. objective response rate [ Time Frame: 36 months for recrutment and 30 months for follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069796

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

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01069796     History of Changes
Other Study ID Numbers: A-Taxel (GINECO BR108)
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic