Spots Global Cancer Trial Database for Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer
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Trial Identification
Brief Title: Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer
Official Title: Phase II Study of Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER2-Negative Breast Cancer
Study ID: NCT00866905
Conditions
Study Description
Brief Summary: We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.
Detailed Description: In this study, patients with early stage, HER2-negative breast cancer will receive neoadjuvant treatment with ixabepilone and cyclophosphamide given every three weeks for a total of six cycles. Following surgery patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Patients may receive local regional radiation therapy after surgery per institutional guidelines at the investigator's discretion. Baseline tumor tissue and tumor tissue removed at the time of surgery will be tested by Oncotype Detailed Description (DX) assay to determine whether it is predictive of response to this neoadjuvant treatment regimen. This study will be one of the first investigations of the combination of ixabepilone and cyclophosphamide as neoadjuvant treatment for HER2-negative breast cancer. It will examine this treatment regimen for potential advantages gained from substitution of ixabepilone for a taxane and use of non-anthracycline agents.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Aventura Medical Center, Aventura, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Watson Clinic Center for Cancer Care and Research, Lakeland, Florida, United States
Medical Oncology Associates of Augusta, Augusta, Georgia, United States
Northeast Georgia Medical Center, Gainesville, 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
St. Louis Cancer Care, Chesterfield, Missouri, United States
Methodist Cancer Center, Omaha, Nebraska, United States
Hematology Oncology Associates of Northern NJ, Morristown, New Jersey, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Cancer Centers of Southwest Oklahoma, Lawton, Oklahoma, United States
South Carolina Oncology Associates, PA, Columbia, South Carolina, United States
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
Family Cancer Center, Collierville, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
South Texas Oncology and Hematology, San Antonio, Texas, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Contact Details
Name: Denise A Yardley, M.D.
Affiliation: SCRI Development Innovations, LLC
Role: STUDY_CHAIR
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