Status:
COMPLETED
Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer
Lead Sponsor:
Harold J. Burstein, MD, PhD
Collaborating Sponsors:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
This study is broken into 4 groups (A, B, C, and D). Enrollment closed to all groups in May 2008. The first forty subjects (Group A) in this study were treated with Bevacizumab only, which is given t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00121134
Start Date
June 1 2005
End Date
May 1 2011
Last Update
December 24 2013
Active Locations (5)
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1
University of California, San Francisco
San Francisco, California, United States, 94122
2
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115