Clinical Trials

A Phase II Study of Adjuvant Bevacizumab, Metronomic Chemotherapy, Diet, and Exercise After Preoperative Chemotherapy for Breast Cancer

Protocol
11-063
Full Title
ABCDE: A Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise after Neoadjuvant Chemotherapy for Breast Cancer
Purpose

Women who have breast cancer remaining after preoperative chemotherapy and breast cancer surgery have a higher risk of the disease returning in the future. There is no chemotherapy that has been shown to reduce the risk of recurrence in these women.

In this study, researchers will evaluate the safety and effectiveness of giving bevacizumab and metronomic chemotherapy to women who had preoperative chemotherapy and had residual breast cancer removed with surgery. With metronomic chemotherapy, repetitive, low doses of chemotherapy drugs are given, which are designed to minimize side effects and target the endothelium, or tumor stroma, as opposed to targeting the tumor itself. The drugs used in this study will be cyclophosphamide and methotrexate given over a six-month period.

Investigators also want to determine if a diet and exercise program can lead to weight low, improved mood, decreased fatigue, and changes in blood markers associated with breast cancer. Patients will be randomly assigned to one of four groups:

  • bevacizumab, metronomic chemotherapy, and dietary and exercise intervention
  • bevacizumab, metronomic chemotherapy, and dietary intervention
  • dietary and exercise intervention
  • dietary intervention alone
Investigator
Maura N. Dickler, MD
Maura N. Dickler - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have residual invasive breast cancer remaining following preoperative chemotherapy containing an anthracycline drug, a taxane, or both.
  • Patients with triple-negative tumors may have stage I-III disease. Those with ER/PR-positive tumors may participate if the tumor is stage III. Patients with HER2-positive tumors or stage IV disease may not participate.
  • Patients must complete surgery to remove the breast cancer.
  • Patients may not have had prior bevacizumab or other anti-angiogenic drugs.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Maura Dickler at 646-888-4560.

Disease(s)
Breast Cancer
Locations
Related Diseases