Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to study the effects (good and bad) of bevacizumab alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to:

• Examine the safety of these drugs

• See how easy or difficult it is to be treated with them

• Monitor for any signs of recurrent cancer

• Look at blood markers that might indicate how the treatment is working

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harold J. Burstein, MD, PhD
• Collaborators: Beth Israel Deaconess Medical Center; Genentech, Inc.; Indiana University School of Medicine; University of California, San Francisco; University of North Carolina
• Treatments: Bevacizumab; Capecitabine; Cyclophosphamide; Methotrexate

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging

• Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.

• Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.

• For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.

• Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.

• LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.

• ECOG performance status 0-1

Exclusion Criteria:

• Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment

• Patients with metastatic disease are ineligible.

• Known HIV infection

• Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding

• Uncontrolled intercurrent illness

• Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment

• History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab

• Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded

• History of bleeding diathesis or coagulopathy

• History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)

• Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer

• Patients with large or rapidly accumulating pleural or abdominal effusions

• Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR

• Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed

• Patients may not receive other investigational agents while on study