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
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Triple Negative Metastatic Breast Cancer
- Sponsor
- ARCAGY/ GINECO GROUP
- Enrollment
- 64
- Locations
- 17
- Primary Endpoint
- objective response rate
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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).
Investigators
Eligibility 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
Arms & Interventions
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
Intervention: Paclitaxel
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
Intervention: Bevacizumab
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
Intervention: Capecitabine
Outcomes
Primary Outcomes
objective response rate
Time Frame: 36 months for recrutment and 30 months for follow up