NCT00915603

Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Weekly Paclitaxel/Bevacizumab +/- Everolimus as First-Line Chemotherapy for Patients With HER2-Negative Metastatic Breast Cancer (MBC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus 10mg PO daily continuously for all 28 days of a cycle
DRUG	Bevacizumab	Bevacizumab 10mg/kg IV Days 1 and 15 of 28 day cycle
DRUG	Paclitaxel	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.
DRUG	Placebo	Placebo PO daily continuously for all 28 days of a cycle
DRUG	Bevacizumab	Bevacizumab 10mg/kg IV days 1 and 15 of 28 day cycle
DRUG	Paclitaxel	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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2009-06-08
• Last updated: 2014-12-22
• Results posted: 2014-12-22

Locations

15 sites across 1 country: United States