Status:
COMPLETED
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Celgene Corporation
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 g...
Detailed Description
All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, pat...
Eligibility Criteria
Inclusion
- Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
- Clinical stage T 1-4, N 0-3, M0
- FISH+ HER2 gene amplified breast cancer
- 18 years or older
- Normal cardiac function
- Performance status 0-2
- Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
- Previous diagnosis of noninvasive breast cancer is OK.
- Must have adequate bone marrow, renal and liver function.
- Pregnant or lactating females not allowed.
- Preexisting peripheral neuropathy must be equal to or less than grade 1
- Must have archived tumor tissue for tissue testing.
Exclusion
- You cannot be in this study if you any of the following:
- History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure
- Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
- No prior investigational drug within the last 30 days
- No prior trastuzumab or bevacizumab therapy
- There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00392392
Start Date
October 1 2006
End Date
December 1 2011
Last Update
September 20 2013
Active Locations (6)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
3
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
4
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503