Breast Cancer Clinical Trial

Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer

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 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.

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Full 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, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor.

Induction preoperative therapy:

Bevacizumab
Trastuzumab
ABI-007
Carboplatin

Postoperative Adjuvant Therapy:

Bevacizumab
Trastuzumab

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

29

Study ID:

NCT00392392

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

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There are 6 Locations for this study

See Locations Near You

Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Grand Rapids Clinical Oncology Program
Grand Rapids Michigan, 49503, United States
Chattanooga Oncology Hematology Associates
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37023, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

29

Study ID:

NCT00392392

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

How clear is this clinincal trial information?

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