Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

Phase 2

Terminated

• Conditions: Triple Negative Metastatic Breast Cancer
• Interventions: Drug: Paclitaxel; Drug: Bevacizumab; Drug: Capecitabine

• Registration Number: NCT01069796
• Lead Sponsor: ARCAGY/ GINECO GROUP

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Study Start: 2010-04
• Primary Completion: 2012-03
• Study Completion: 2014-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 64

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Association bevacizumab paclitaxel capecitabine breast cancer	Paclitaxel	* 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
Association bevacizumab paclitaxel capecitabine breast cancer	Capecitabine	* 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
Association bevacizumab paclitaxel capecitabine breast cancer	Bevacizumab	* 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

Primary Outcome Measures

Name	Time	Method
objective response rate	36 months for recrutment and 30 months for follow up

Trial Locations

Locations (17)

Centre Paul Papin; 🇫🇷 Angers, France

Hôpital Privé Clairval; 🇫🇷 Marseille, France

Centre Hospitalier Bretagne Atlantique; 🇫🇷 Vannes, France

Centre Hospitalier Intercommunal; 🇫🇷 Fréjus, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Clinique de l'Union; 🇫🇷 St Jean, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Centre Alexis Vautrin; 🇫🇷 Nancy, France

Clinique des 4 Pavillons; 🇫🇷 Lormont, France

Hôpitaux Drôme Nord - Site de Romans-sur-Isère; 🇫🇷 Romans sur Isère, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Hospitalier William Morey; 🇫🇷 Chalon sur Saône, France

Centre Azuréen de Cancérologie; 🇫🇷 Mougins, France

Centre Hospitalier Régional; 🇫🇷 Orléans, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Institut Jean Godinot; 🇫🇷 Reims, France

Clinique Armoricaine de Radiologie; 🇫🇷 Saint Brieuc, France