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
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Triple Negative Metastatic Breast Cancer
Female
Triple Negative Metastatic Breast Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
objective response rate
Outcome Time Frame:
36 months for recrutment and 30 months for follow up
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
A-Taxel (GINECO BR108)
NCT ID:
NCT01069796
Start Date:
April 2010
Completion Date:
December 2015
Related Keywords:
- Triple Negative Metastatic Breast Cancer
- triple negative
- metastatic
- breast cancer
- First line chemotherapy
- Breast Neoplasms
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