Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer
Status:
Unknown status
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
If residual breast cancer is found in the breast or lymph node tissue removed after
preoperative chemotherapy, one may be at increased risk of breast cancer recurrence in the
future. The purpose of this research study is to determine if having additional treatment
after preoperative chemotherapy and surgery with bevacizumab and metronomic chemotherapy
would make a difference in reducing the participants chance of breast cancer recurrence
compared to the standard of care, which is observation alone. This study will evaluate the
potential additional benefits from participating in an exercise and dietary intervention
compared to the dietary intervention alone. Bevacizumab is an antibody that is made in the
laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Bevacizumab
works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to
tumors. Bevacizumab has been approved by the U.S Food and Drug Administration to treat
advanced colorectal, lung and kidney cancers. Metronomic chemotherapy also attacks tumor
blood supply. Standard chemotherapy drugs are used, cyclophosphamide and methotrexate (CM),
but in very small daily doses by mouth, well below the threshold where they can cause people
to feel sick. Previous research studies have shown that women with breast cancer who take
metronomic CM and bevacizumab feel very well, and the combination therapy is active in
reducing their cancer. Participants in this study will also be provided with diet or diet and
exercise counseling over the telephone. Studies have shown that many women who are treated
for breast cancer will gain weight during and after their treatment, and may also experience
fatigue and weakness. Many studies have shown that making changes in diet and increasing
exercise can help prevent weight gain and also may increase energy and decrease other side
effects of chemotherapy and other breast cancer treatments.
Phase:
Phase 2
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center Brigham and Women's Hospital Genentech, Inc. Translational Breast Cancer Research Consortium