Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymp Node Positive Breast Cancer: A Pilot Study
Approximately 200,000 women are diagnosed with breast cancer in the United States every
year. A significant factor determining long-term survivability of breast cancer is whether
or not lymph nodes, glands which cleanse and filter the body's fluids, are involved.
Despite treatment with approved multiagent cytotoxic chemotherapy ("dose-dense
chemotherapy"), women with breast cancer involving more than 4 axillary lymph nodes still
have a high risk for recurrence.
Several dose-dense chemotherapy regimens are currently being compared in other studies,
however, at this time there is no proof that one regimen is superior to another. Therefore,
in an attempt to decrease metastases, prolong time to recurrence and improve overall
survival, it is essential to develop novel therapeutic strategies. The use of inhibitors of
angiogenesis represents a promising option.
Bevacizumab is the first angiogenesis inhibiting drug to be FDA approved, for the treatment
of colon cancer. It is has also been studied alone in progressed lymph-node positive breast
cancer and has shown moderate efficacy.
This study will observe the efficacy and tolerability of using bevacizumab in combination
with an approved dose-dense chemotherapy regimen for 8 cycles, followed by 12 of bevacizumab
alone. Patients may be on the study for up to 52 weeks if their disease has not progressed
and the regimen is tolerated.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of treatment failure, 2 and 5 year Disease Free Survival.
Linnea I. Chap, MD
Premiere Oncology, A Medical Corporation
United States: Food and Drug Administration
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