Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00405938
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 10mg/kg IV every 2 weeks
  • Anastrozole — DRUG
    anastrozole (1 mg orally daily)
  • Fulvestrant — DRUG
    fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant).

Study Details

This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped that these combinations will keep the cancer from growing and spreading further.

Key Dates

First listed
Nov 30, 2006
Start date
Nov 30, 2006
Status verified
Nov 2021
Primary completion
Jun 30, 2010
Completion
Jun 30, 2011

Study Design

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

Arms

  • Experimental: Bevacizumab/anastrozole
    Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
  • Experimental: Bevacizumab/fulvestrant
    Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant). Treatment will be given in 4-week cycles.

Primary Outcome Measure

Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Integrated Community Oncology NetworkJacksonvilleFlorida32256-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Wellstar Cancer ResearchMariettaGeorgia30060-
Graves-Gilbert ClinicBowling GreenKentucky42101-
Baton Rouge General Medical CenterBaton RougeLouisiana70806-
St. Louis Cancer CareChesterfieldMissouri63017-
Sletten Cancer InstituteGreat FallsMontana59405-
Chattanooga Oncology & Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37203-

Find similar trials in Fort Myers, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Florida Cancer Specialists· Fort Myers, FLIntegrated Community Oncology Network· Jacksonville, FLFlorida Hospital Cancer Institute· Orlando, FLNortheast Georgia Medical Center· Gainesville, GAWellstar Cancer Research· Marietta, GAGraves-Gilbert Clinic· Bowling Green, KY

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