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

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT00121134

Run by

Harold J. Burstein, MD, PhD

People needed

164

Starts

2005-06-01

Expected to finish

2011-05-01

Last updated by the study team

2013-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of North Carolina — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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