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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00392392

Run by

SCRI Development Innovations, LLC

People needed

29

Starts

2006-10-01

Expected to finish

2011-12-01

Last updated by the study team

2013-09-20

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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