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Phase II Study of Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer
In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior to surgery; after surgery, patients will continue treatment with trastuzumab every three weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the completion of chemotherapy, patients may receive radiation treatment at the discretion of their physician.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Florida Cancer Specialists
Fort Myers, Florida, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, United States
Providence Medical Group
Terre Haute, Indiana, United States
Mercy Hospital
Portland, Maine, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
St. Louis Cancer Care
Chesterfield, Missouri, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Start Date
February 1, 2009
Primary Completion Date
July 1, 2011
Completion Date
October 1, 2014
Last Updated
December 22, 2014
60
ACTUAL participants
Ixabepilone
DRUG
Trastuzumab
DRUG
Carboplatin
DRUG
Lead Sponsor
SCRI Development Innovations, LLC
Collaborators
NCT04704661
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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