Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Paclitaxel Bevacizumab Everolimus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 113
Healthy volunteers: no

Brief summary:
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/ bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations every 8 weeks, until tumor progression or

intolerable toxicity occurs. Outcomes will be assessed for each treatment arm

separately. This trial is not intended to compare treatment arms primarily. Any such analyses are exploratory and will be conducted without adjustment for multiple hypothesis testing.

Detailed description:

Arms:
arm 1: Systemic Therapy arm 2: Systemic Therapy

Interventions: intervention 1: Everolimus intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Placebo intervention 5: Bevacizumab intervention 6: Paclitaxel
Intervention descriptions: intervention 1: Everolimus 10mg PO daily continuously for all 28 days of a cycle intervention 2: Bevacizumab 10mg/kg IV Days 1 and 15 of 28 day cycle intervention 3: Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction. intervention 4: Placebo PO daily continuously for all 28 days of a cycle intervention 5: Bevacizumab 10mg/kg IV days 1 and 15 of 28 day cycle intervention 6: Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction.

Protocol document: