Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Harold J. Burstein, MD, PhD
Study ID
NCT00670982
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    Given intravenously every 2 weeks
  • vinorelbine — DRUG
    Given intravenously once a week
  • trastuzumab — DRUG
    Given intravenously once a week

Study Details

The purpose of this research study is to determine the effects of the combination of bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.

Key Dates

Start date
May 31, 2008
Status verified
Mar 2013
Primary completion
Dec 31, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: First line treatment
    Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
  • Experimental: Second line treatment
    Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.

Primary Outcome Measure

Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy. [ Time Frame: 1 year ]

Locations (7)

FacilityCityStateZIPSite coordinators
Hartford HospitalHartfordConnecticut06101-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Faulkner HospitalBostonMassachusetts02130-
Massachusetts General HospitalBostonMassachusetts02114-
Lowell General HospitalLowellMassachusetts01850-
New Hampshire Oncology-Hematology PAHooksettNew Hampshire03106-

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