Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

Triple Negative Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01069796
• Other study ID #: A-Taxel (GINECO BR108)
• Status: Terminated
• Phase: Phase 2
• First received: February 16, 2010
• Last updated: March 15, 2016
• Start date: April 2010
• Est. completion date: June 2014

Study information

• Verified date: March 2016
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: CPP
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: June 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Metastatic Breast Cancer

Intervention

Drug:
• Paclitaxel
80 mg/m² weekly
• Bevacizumab
10 mg/kg d1 d15
• Capecitabine
800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 & 3

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		36 months for recrutment and 30 months for follow up	No