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

Sponsors and Collaborators:	Sarah Cannon Research Institute Sarah Cannon Oncology Research Consortium Abraxis BioScience Inc. Genentech
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00392392

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: ABI-007 Drug: Bevacizumab Drug: Trastuzumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Paclitaxel Bevacizumab Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

pathologic response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2009
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABI-007 ABI-007 Drug: Bevacizumab Bevacizumab Drug: Trastuzumab Trastuzumab

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, 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392392

Locations

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

Sponsors and Collaborators

Sarah Cannon Research Institute

Sarah Cannon Oncology Research Consortium

Abraxis BioScience Inc.

Genentech

Investigators

Principal Investigator:

Denise Yardley, MD

Sarah Cannon Research Institute

More Information

Responsible Party:	SCRI Oncology Research Consortium ( Denise A. Yardley, M.D. )
Study ID Numbers:	SCRI BRE 83
Study First Received:	October 25, 2006
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00392392
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sarah Cannon Research Institute:

Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Trastuzumab
Breast Neoplasms

Carboplatin
Bevacizumab
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009