Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer
- Sponsor
- ARCAGY/ GINECO GROUP
- Study ID
- NCT01069796
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Triple Negative Metastatic Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Paclitaxel — DRUG80 mg/m² weekly
- Bevacizumab — DRUG10 mg/kg d1 d15
- Capecitabine — DRUG800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 \& 3
Study Details
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).
Key Dates
- First listed
- Feb 17, 2010
- Start date
- Apr 30, 2010
- Status verified
- Mar 2016
- Primary completion
- Mar 31, 2012
- Completion
- Jun 30, 2014
Study Design
- Enrollment
- 64 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- 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
Primary Outcome Measure
objective response rate [ Time Frame: 36 months for recrutment and 30 months for follow up ]