A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer
Overview[ - collapse ][ - ]
Purpose | This is a randomized, Phase III, open-label, multicenter study. |
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Condition | Breast Cancer |
Intervention | Drug: Doxorubicin Drug: Cyclophosphamide Drug: Ixabepilone (Ixempra) Drug: Paclitaxel (Taxol) |
Phase | Phase 3 |
Sponsor | SCRI Development Innovations, LLC |
Responsible Party | SCRI Development Innovations, LLC |
ClinicalTrials.gov Identifier | NCT00789581 |
First Received | November 11, 2008 |
Last Updated | January 22, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | November 11, 2008 |
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Last Updated Date | January 22, 2014 |
Start Date | January 2009 |
Estimated Primary Completion Date | January 2016 |
Current Primary Outcome Measures | To compare the disease-free survival (DFS) of women with triple-negative early-stage breast cancer following adjuvant treatment with AC followed by every-3-week ixabepilone vs. AC followed by weekly paclitaxel. [Time Frame: 5 years] [Designated as safety issue: No] |
Current Secondary Outcome Measures | To compare the overall survival. To assess the safety. To compare the DFS. [Time Frame: 5 years] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer |
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Official Title | Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer |
Brief Summary | This is a randomized, Phase III, open-label, multicenter study. |
Detailed Description | Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | Drug: Doxorubicin Doxorubicin 60 mg/m2 Other Names:
Cyclophosphamide 600 mg/m2 Other Names:
Ixabepilone 40 mg/m2 Other Names:
Paclitaxel 80 mg/m2 Other Names: Taxol |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 614 |
Estimated Completion Date | January 2016 |
Estimated Primary Completion Date | January 2015 |
Eligibility Criteria | Inclusion Criteria: 1. Female patients greater than or equal to18 years of age. 2. Histologically confirmed invasive unilateral breast cancer (regardless of histology). 3. Early-stage breast cancer, defined as: - Node-positive disease: >0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR - Node-negative, with primary tumor >1.0 cm (T1c-T3). 4. Definitive loco-regional surgery must have been completed as specified below: - Patients must have undergone either breast conservation surgery (i.e., lumpectomy) or total mastectomy. - Surgical margins of the resected section must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ. - Surgical margins involved with lobular carcinoma in situ (LCIS) will not be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection. - Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below: Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection. 5. Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above. 6. Patients with synchronous bilateral cancers are eligible only if: - All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-. - Eligibility based on the highest stage grouping. 7. HER2 negative tumors. HER2 negativity must be confirmed by one of the following: - FISH-negative (FISH ratio <2.2), or - IHC 0-1+, or - IHC 2-3+ AND FISH-negative (FISH ratio <2.2). 8. Estrogen receptor negative (<10% staining by IHC for estrogen receptor). 9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 10. Patient must be <= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy). 11. MammoSite brachytherapy radiation is acceptable if it is performed immediately following surgery and prior to chemotherapy. It is recommended that chemotherapy be started no earlier than 2 weeks following the removal of the MammoSite balloon catheter. 12. Adequate hematologic function, defined by: - Absolute neutrophil count (ANC) >1500/mm3 - Platelet count >=100,000/mm3 - Hemoglobin >9 g/dL 13. Adequate liver function, defined by: - AST and ALT <=2.5 x the upper limit of normal (ULN) - Total bilirubin <=1.5 x ULN (unless the patient has grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin). 14. Adequate renal function, defined by: · Serum creatinine <=1.5 x ULN 15. Complete staging work-up <=12 weeks prior to initiation of study treatment with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), and either a positron emission tomography (PET) scan or a bone scan. 16. Adequate cardiac function, defined by a left ventricular ejection fraction (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO). 17. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure). 18. Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease. 19. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. 20. Patient must be accessible for treatment and follow-up. 21. Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter. 22. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. History of previous diagnosis of invasive breast cancer (unless treated >5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable. 3. Any evidence or suspicion of metastatic disease other than ipsilateral axillary lymph nodes. 4. Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer). 5. Previous anthracycline chemotherapy. 6. Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of study treatment until the end of treatment with ixabepilone. 7. Previous treatment for this breast cancer (including neoadjuvant chemotherapy). 8. Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer). 9. Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0. 10. Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. 11. History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or a drug formulated in CremophorEL such as paclitaxel. 12. Use of any investigational agent within 30 days of administration of the first dose of study drug. 13. Patients may not receive any other investigational or anti-cancer treatments while participating in this study. 14. Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. 15. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study. 16. Inability to comply with study and/or follow-up procedures. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Puerto Rico |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00789581 |
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Other Study ID Numbers | SCRI BRE 145 |
Has Data Monitoring Committee | Yes |
Information Provided By | SCRI Development Innovations, LLC |
Study Sponsor | SCRI Development Innovations, LLC |
Collaborators | Bristol-Myers Squibb |
Investigators | Study Chair: Denise A Yardley, M.D. SCRI Development Innovations, LLC |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Northeast Alabama Regional Medical Center | Anniston, Alabama, United States, 36207 |
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Cancer Center of Huntsville | Huntsville, Alabama, United States, 35801 |
Clearview Cancer Institute | Huntsville, Alabama, United States, 35805 |
University of Southern Alabama | Mobile, Alabama, United States, 36604 |
Northeast Arkansas Clinic | Jonesboro, Arkansas, United States, 72401 |
Wilshire Oncology Medical Group | LaVerne, California, United States, 91750 |
New Hope Cancer and Research Institute | Pomona, California, United States, 91767 |
Eastern Connecticut Hematology Oncology | Norwich, Connecticut, United States, 06360 |
Aventura Medical Center | Aventura, Florida, United States, 33180 |
Lynn Cancer Institute | Boca Raton, Florida, United States, 33428 |
Florida Cancer Care | Davie, Florida, United States, 33328 |
Florida Cancer Specialists | Fort Myers, Florida, United States, 33901 |
Holy Cross Hospital | Ft. Lauderdale, Florida, United States, 33308 |
Memorial Regional Cancer Center | Hollywood, Florida, United States, 33021 |
Integrated Community Oncology Network | Jacksonville, Florida, United States, 32256 |
Watson Clinic Center for Cancer Care and Research | Lakeland, Florida, United States, 33805 |
Space Coast Medical Associates | Titusville, Florida, United States, 32796 |
Piedmont Healthcare | Atlanta, Georgia, United States, 30309 |
Emory/Winship Cancer Institute | Atlanta, Georgia, United States, 30322 |
Augusta Oncology Associates | Augusta, Georgia, United States, 30901 |
Medical Oncology Associates of Augusta | Augusta, Georgia, United States, 30901 |
Medical College of Georgia Cancer Specialists | Augusta, Georgia, United States, 30912 |
Northeast Georgia Medical Center | Gainesville, Georgia, United States, 30501 |
Suburban Hem Onc | Lawrenceville, Georgia, United States, 30045 |
Mid-Illinois Hematology & Oncology | Normal, Illinois, United States, 61761 |
Hematology Oncology of the North Shore | Skokie, Illinois, United States, 60076 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana, United States, 47714 |
Hematology Oncology of Indiana | Indianapolis, Indiana, United States, 46260 |
Providence Medical Group | Terre Haute, Indiana, United States, 47802 |
Kansas City Cancer Centers | Overland Park, Kansas, United States, 66210 |
Cotton O'Neil Cancer Center | Topeka, Kansas, United States, 66606 |
Consultants in Blood Disorders and Cancer | Louisville, Kentucky, United States, 40207 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana, United States, 70806 |
Mercy Hospital | Portland, Maine, United States, 04101 |
Weinberg Cancer Institute at Franklin Square | Baltimore, Maryland, United States, 21237 |
Center for Cancer and Blood Disorders | Bethesda, Maryland, United States, 20817 |
Fallon Clinic | Worchester, Massachusetts, United States, 01608 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan, United States, 49503 |
Fairview Medical Oncology Clinic | Edina, Minnesota, United States, 55436 |
St. Louis Cancer Care | Chesterfield, Missouri, United States, 63017 |
Research Medical Center | Kansas City, Missouri, United States, 64132 |
St. John's Clinic | Springfield, Missouri, United States, 65804 |
Methodist Cancer Center | Omaha, Nebraska, United States, 68114 |
St. Clare's Hospital Oncology and Hematology | Denville, New Jersey, United States, 07834 |
Hematology Oncology Associates of Northern NJ | Morristown, New Jersey, United States, 07960 |
Southern Oncology and Hematology | Vineland, New Jersey, United States, 08360 |
New Mexico Oncology Hematology Consultants | Albuquerque, New Mexico, United States, 87109 |
Alamance Regional Medical Center | Burlington, North Carolina, United States, 27215 |
Oncology Hematology Care | Cincinnati, Ohio, United States, 45242 |
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center | Columbus, Ohio, United States, 43219 |
Hematology/Oncology Inc | Elyria, Ohio, United States, 44035 |
Hickman Cancer Center (Flower Hospital) | Sylvania, Ohio, United States, 43560 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, United States, 15213 |
Bux-Mont Oncology, Fox Chase Cancer Center | Rockledge, Pennsylvania, United States, 18960 |
Medical University of South Carolina | Charleston, South Carolina, United States, 29425 |
South Carolina Oncology Associates, PA | Columbia, South Carolina, United States, 29210 |
Lowcountry Hematology Oncology | Mt. Pleasant, South Carolina, United States, 29464 |
Coastal Cancer Center | Myrtle Beach, South Carolina, United States, 29572 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina, United States, 29303 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee, United States, 37404 |
Associates in Hematology Oncology | Chattanooga, Tennessee, United States, 37404 |
Family Cancer Center | Collierville, Tennessee, United States, 38017 |
Tennessee Oncology, PLLC | Nashville, Tennessee, United States, 37023 |
Coastal Bend Cancer Center | Corpus Christi, Texas, United States, 78463 |
Center for Cancer and Blood Disorders | Ft. Worth, Texas, United States, 76104 |
Medical Oncology Methodist Hospital | Houston, Texas, United States, 77030 |
South Texas Oncology and Hematology | San Antonio, Texas, United States, 78258 |
Peninsula Cancer Institute | Newport News, Virginia, United States, 23601 |
Virginia Cancer Institute | Richmond, Virginia, United States, 23235 |
San Juan Hospital | San Juan, Puerto Rico |