ABCDE: A Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer
- Because no one knows which of the study options are best, participants will be
"randomized" to one of the study groups: 1. Diet Intervention arm, 2. Diet and
Exercise Intervention Arm, 3. Bevacizumab, cyclophosphamide, methotrexate and diet
intervention, 4. Bevacizumab, cyclophosphamide, methotrexate, diet and exercise
intervention arm.
- Participants assigned to groups 1 or 2 will receive a diet intervention or diet and
exercise intervention. They will be seen by the doctor for physical examination every
12 weeks for the first two years during the intervention, and then on an every 6 month
basis. Routine laboratory testing will be done at the time of the visits as well.
Other blood tests will be done to measure the effect of the diet and exercise
interventions at the beginning of the treatment, at 6 months, and at 1 year from the
start of the treatment. Additionally, one blood test will be done at the beginning of
the treatment to look for hereditary differences in genes related to metabolism.
- Participants assigned to groups 3 or 4 will undergo the following: Medication:
Participants that are placed in the bevacizumab and cyclophosphamide and methotrexate
(CM) arm will receive bevacizumab intravenously once every 3 weeks for approximately 6
months, followed by every 6 week treatments for additional 1.5 years; cyclophosphamide
orally once a day and methotrexate orally twice a day for the first two days of each
week. The treatments with CM therapy and bevacizumab will continue for approximately 6
months. Physical Exams: once 6 weeks of drug therapy (2 cycles)is completed, physical
examination frequency is reduced to every 6 weeks (every other cycle) for the
additional 6 cycles. Once 24 weeks of drug therapy (8 cycles or about 6 months since
the start of therapy) are completed, physical examination will be done every 12 weeks
for the duration of protocol therapy. Blood Tests: chemistry and hematology testing
will be done prior to start of Cycles 1, 2 and 3 and then every 6 weeks (every other
cycle) for the duration of cyclophosphamide and methotrexate chemotherapy. After 24
weeks (8 cycles) of drug treatment, hematology/chemistry testing frequency can be
reduced to every 12 weeks (every other cycle) for the rest of bevacizumab treatment.
Urine Tests will be done every other cycle for the duration of treatment. Heart
function testing by echocardiogram will be done at 6 months, 1, 2, and 3 years after
participants start the study. Ultrasound of the blood vessels will be done on those
randomized to receive bevacizumab with CM chemotherapy. This test will be done at
baseline and after completion of the first and second cycles of therapy.
- Activities for all Groups: Lifestyle Intervention: All women in this study will
complete a number of tests at baseline, 6 and 12 months. Diet Only Group:
Participants assigned to this group will be asked to participate in a series of 13
telephone calls over the course of 1 year with. Those assigned to the Diet and
Exercize Group (in addition to the information listed above) will receive counseling
targeted toward increasing physical activity.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recurrence-free survival
To compare the recurrence-free survival, defined as time on study before local, regional, or distant tumor recurrence, in patients who are randomized to post-neoadjuvant angiogenesis inhibitor therapy compared to those who are randomized to not receive the angiogenesis inhibitor therapy.
2 years
No
Erica Mayer, MD
Study Chair
Dana-Farber Cancer Institute
United States: Food and Drug Administration
09-134
NCT00925652
September 2010
September 2017
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Faulkner Hospital | Jamaica Plain, Massachusetts 02130 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599 |
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | Milford, Massachusetts 01757 |
Indiana Unversity Simon Cancer Center | Indianapolis, Indiana 46202 |