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

Part of paid clinical trials in LaVerne, California.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00915603
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 8, 2009
Start date
Jul 31, 2009
Status verified
Dec 2014
Primary completion
Jun 30, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
113 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: paclitaxel/bevacizumab/everolimus
    Systemic Therapy
  • Placebo Comparator: paclitaxel/bevacizumab/placebo
    Systemic Therapy

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: every 8 weeks until progressive disease, expected average of 18 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
Wilshire Oncology Medical GroupLaVerneCalifornia91750-
Eastern Connecticut Hematology OncologyNorwichConnecticut06360-
Aventura Medical CenterAventuraFlorida33180-
Florida Cancer SpecialistsFort MyersFlorida33901-
Mercy HospitalPortlandMaine04101-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
National Capital Clinical Research AssociatesBethesdaMaryland20817-
Oncology Hematology CareCincinnatiOhio45242-
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister CenterColumbusOhio43219-
South Carolina Oncology Associates, PAColumbiaSouth Carolina29210-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-
Texas OncologyDallasTexas75246-
Fairfax Northern Virginia Hem-OncFairfaxVirginia22031-
Virginia Cancer InstituteRichmondVirginia23235-

Find similar trials in LaVerne, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Wilshire Oncology Medical Group· LaVerne, CAEastern Connecticut Hematology Oncology· Norwich, CTAventura Medical Center· Aventura, FLFlorida Cancer Specialists· Fort Myers, FLMercy Hospital· Portland, MECenter for Cancer and Blood Disorders· Bethesda, MD

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