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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bristol-Myers Squibb |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00866905 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Ixabepilone Drug: Cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER2-Negative Breast Cancer |
Estimated Enrollment: | 166 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Systemic Therapy followed by surgery and possible radiation therapy
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Drug: Ixabepilone
40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles
Drug: Cyclophosphamide
600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles
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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 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
No metastatic disease, as documented by complete staging workup
HER2-negative tumor status. HER2-negative is defined as:
Adequate hematologic function with:
Adequate hepatic function with:
Exclusion Criteria:
Contact: Denise A Yardley, M.D. | 615-329-7274 | dyardley@tnonc.com |
Contact: Trials Info | 615-329-7274 | trialsinfo@scresearch.net |
United States, Indiana | |
Providence Medical Group | Recruiting |
Terre Haute, Indiana, United States, 47802 | |
United States, Maryland | |
Center for Cancer and Blood Disorders | Recruiting |
Bethesda, Maryland, United States, 20817 | |
United States, Missouri | |
St. Louis Cancer Care | Recruiting |
Chesterfield, Missouri, United States, 63017 | |
United States, Tennessee | |
Tennessee Oncology | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Trials Information 615-329-7274 trialsinfo@scresearch.net | |
United States, Texas | |
South Texas Oncology and Hematology | Recruiting |
San Antonio, Texas, United States, 78258 |
Study Chair: | Denise A Yardley, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( Denise A. Yardley ) |
Study ID Numbers: | SCRI BRE 133 |
Study First Received: | March 19, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00866905 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Ixabepilone Ixempra |
Cyclophosphamide Cytoxan Neoadjuvant Therapy |
Immunologic Factors Skin Diseases Epothilones Tubulin Modulators Breast Neoplasms Antimitotic Agents |
Antineoplastic Agents, Alkylating Cyclophosphamide Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Epothilones Mitosis Modulators Physiological Effects of Drugs Breast Neoplasms Antimitotic Agents Cyclophosphamide Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |