Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00119262
Phase
PHASE2
Status
Completed

Conditions

  • Male Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer

Eligibility Criteria

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

Interventions

  • doxorubicin hydrochloride — DRUG
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • paclitaxel — DRUG
    Given IV
  • filgrastim — BIOLOGICAL
    Given SC
  • pegfilgrastim — BIOLOGICAL
    Given SC
  • radiation therapy — RADIATION
    Undergo radiation therapy
  • tamoxifen citrate — DRUG
    Given orally
  • aromatase inhibition therapy — DRUG
    Receive aromatase inhibition therapy

Study Details

This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.

Key Dates

First listed
Jul 13, 2005
Start date
Oct 31, 2005
Status verified
Dec 2012
Primary completion
Aug 31, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
226 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (combination chemotherapy, 18 courses of bevacizumab)
    See detailed description.
  • Active Comparator: Arm II (combination chemotherapy, 22 courses of bevacizumab)
    See detailed description.

Primary Outcome Measure

Congestive Heart Failure Rate [ Time Frame: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry ]

Locations (1)

FacilityCityStateZIPSite coordinators
Eastern Cooperative Oncology GroupBostonMassachusetts02215-

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By research site
Eastern Cooperative Oncology Group· Boston, MA

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