None listed
Conditions
Interventions
BEVACIZUMAB Type of group
Paclitaxel: 90 mg / m2 IV infusion in 1 hour every week x 3 weeks followed by 1 week of rest.
BEVACIZUMAB: 10 mg / Kg. following treatment with Paclitaxel in weeks 1 and 3 of each cycle. Treatment duration: 18 cycles
Group name:PACLITAXE Type of group
PACLITAXEL: 90 mg / m2 IV infusion. in 1 hour each week x 3 weeks, followed by 1 week of rest.
Treatment duration: 18 cycles
Sponsors
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Eligibility
Inclusion criteria
Inclusion criteria: Patients must be 18 years of age or older with a histological diagnosis or cytologic diagnosis of breast adenocarcinoma with recurrent disease or measurable metastatic or not, which is not amenable to resection with Healing attempt. Patients should not be pregnant or breastfeeding, and if they had reproductive potential they should use effective contraceptive methods during treatment.
Exclusion criteria
Exclusion criteria: Be a minor Be pregnant. They should not have open wounds or fractures. They should not be using Aspirin (> 325 mg / day) or other NSAIDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Failure time to treatment Measure:Time to treatment failure in patients who have not received chemotherapy for metastatic disease, randomized to treatment with Paclitaxel alone or Paclitaxel plus Bevacizumab. Timepoints:week 17 and 33 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Objective response rate, response duration, progression-free time, overall survival and toxicity Measure:Objective response rate, duration of response, progression-free time, overall survival and toxicity in the Paclitaxel arm alone and in the Paclitaxel plus Bevacizumab arm. Timepoints:week 17 and 33 | — |
Countries
Peru, United States
Outcome results
None listed