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

PHASE2CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

June 30, 2014

Study Completion Date

July 31, 2014

Conditions
Metastatic Breast Cancer
Interventions
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.

Trial Locations (15)

20817

Center for Cancer and Blood Disorders, Bethesda

National Capital Clinical Research Associates, Bethesda

22031

Fairfax Northern Virginia Hem-Onc, Fairfax

23235

Virginia Cancer Institute, Richmond

29210

South Carolina Oncology Associates, PA, Columbia

33180

Aventura Medical Center, Aventura

33901

Florida Cancer Specialists, Fort Myers

37023

Tennessee Oncology, PLLC, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

43219

Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center, Columbus

45242

Oncology Hematology Care, Cincinnati

75246

Texas Oncology, Dallas

91750

Wilshire Oncology Medical Group, LaVerne

06360

Eastern Connecticut Hematology Oncology, Norwich

04101

Mercy Hospital, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER

NCT00915603 - Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter