Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer
This study is broken into 4 groups (A, B, C, and D). Enrollment closed to all groups in May
The first forty subjects (Group A) in this study were treated with Bevacizumab only, which
is given through a vein over 1-2 hours every 3 weeks, for a total of approximately 12 months
(17 cycles). Each cycle consists of 3 weeks.
The next forty subjects (Group B) were treated with Bevacizumab and metronomic CM
chemotherapy. These subjects took cyclophosphamide (1 pill by mouth every day),
methotrexate, (1 pill taken by mouth twice a day for the first two days of each week) and
Bevacizumab (once every 3 weeks). The treatments with cyclophosphamide, methotrexate and
Bevacizumab will continue for approximately 6 months (8 cycles). Then for the next 6 months,
they received Bevacizumab treatments only. The total time on this study will be about 12
months (17 cycles).
The next forty subjects (Group C) were treated with Bevacizumab and Capecitabine
chemotherapy. These subjects took Capecitabine pills twice a day for 14 days, then one week
of rest, to complete a 21-day cycle. There will be a total of 6 cycles of Capecitabine,
meaning 18 weeks of treatment with both Capecitabine and Bevacizumab. Then received
Bevacizumab treatments only (11 cycles) to complete 12 months of therapy. Total duration of
your treatment will be about 12 months or 17 cycles of therapy.
The last forty subjects (Group D) are being treated with Bevacizumab and Capecitabine
chemotherapy on a different schedule. These subjects will take Capecitabine pills twice a
day for 7 days, then one week of rest and repeat this for a total of 24 weeks (6 cycles).
Each cycle will last for 4 weeks (28 days). There will be a total of 6 cycles of
Capecitabine, meaning 24 weeks of treatment with both Capecitabine and Bevacizumab.
Bevacizumab will be given every two weeks for a total of 24 weeks (6 cycles). Then they will
receive Bevacizumab treatments only, every 3 weeks for additional 27 weeks (9 cycles) to
complete 12 months of therapy. For the last 9 cycles of Bevacizumab therapy each cycle will
consist of 3 weeks. Total duration of treatment will be about 12 months or 15 cycles of
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of bevacizumab administration with or without concurrent use of metronomic chemotherapy or capecitabine therapy in the adjuvant setting in women with breast cancer previously treated with preoperative chemotherapy.
Harold J Burstein, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|University of California, San Francisco||San Francisco, California 94143|
|University of North Carolina||Chapel Hill, North Carolina 27599|