A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer
This trial is active, not recruiting.
|Treatments||doxorubicin, cyclophosphamide, ixabepilone (ixempra), paclitaxel (taxol)|
|Sponsor||SCRI Development Innovations, LLC|
|Start date||January 2009|
|End date||December 2015|
|Trial size||614 participants|
|Trial identifier||NCT00789581, SCRI BRE 145, TITAN|
This is a randomized, Phase III, open-label, multicenter study.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Anniston, AL||Northeast Alabama Regional Medical Center||no longer recruiting|
|Huntsville, AL||Cancer Center of Huntsville||no longer recruiting|
|Huntsville, AL||Clearview Cancer Institute||no longer recruiting|
|Mobile, AL||University of Southern Alabama||no longer recruiting|
|Jonesboro, AR||Northeast Arkansas Clinic||no longer recruiting|
|LaVerne, CA||Wilshire Oncology Medical Group||no longer recruiting|
|Pomona, CA||New Hope Cancer and Research Institute||no longer recruiting|
|Norwich, CT||Eastern Connecticut Hematology Oncology||no longer recruiting|
|Aventura, FL||Aventura Medical Center||no longer recruiting|
|Boca Raton, FL||Lynn Cancer Institute||no longer recruiting|
|Davie, FL||Florida Cancer Care||no longer recruiting|
|Fort Myers, FL||Florida Cancer Specialists||no longer recruiting|
|Ft. Lauderdale, FL||Holy Cross Hospital||no longer recruiting|
|Hollywood, FL||Memorial Regional Cancer Center||no longer recruiting|
|Jacksonville, FL||Integrated Community Oncology Network||no longer recruiting|
|Lakeland, FL||Watson Clinic Center for Cancer Care and Research||no longer recruiting|
|Titusville, FL||Space Coast Medical Associates||no longer recruiting|
|Atlanta, GA||Piedmont Healthcare||no longer recruiting|
|Atlanta, GA||Emory/Winship Cancer Institute||no longer recruiting|
|Augusta, GA||Augusta Oncology Associates||no longer recruiting|
|Augusta, GA||Medical Oncology Associates of Augusta||no longer recruiting|
|Augusta, GA||Medical College of Georgia Cancer Specialists||no longer recruiting|
|Gainesville, GA||Northeast Georgia Medical Center||no longer recruiting|
|Lawrenceville, GA||Suburban Hem Onc||no longer recruiting|
|Normal, IL||Mid-Illinois Hematology & Oncology||no longer recruiting|
|Skokie, IL||Hematology Oncology of the North Shore||no longer recruiting|
|Evansville, IN||Oncology Hematology Associates of SW Indiana||no longer recruiting|
|Indianapolis, IN||Hematology Oncology of Indiana||no longer recruiting|
|Terre Haute, IN||Providence Medical Group||no longer recruiting|
|Overland Park, KS||Kansas City Cancer Centers||no longer recruiting|
|Topeka, KS||Cotton O'Neil Cancer Center||no longer recruiting|
|Louisville, KY||Consultants in Blood Disorders and Cancer||no longer recruiting|
|Baton Rouge, LA||Baton Rouge General Medical Center||no longer recruiting|
|Portland, ME||Mercy Hospital||no longer recruiting|
|Baltimore, MD||Weinberg Cancer Institute at Franklin Square||no longer recruiting|
|Bethesda, MD||Center for Cancer and Blood Disorders||no longer recruiting|
|Worchester, MA||Fallon Clinic||no longer recruiting|
|Grand Rapids, MI||Grand Rapids Clinical Oncology Program||no longer recruiting|
|Edina, MN||Fairview Medical Oncology Clinic||no longer recruiting|
|Chesterfield, MO||St. Louis Cancer Care||no longer recruiting|
|Kansas City, MO||Research Medical Center||no longer recruiting|
|Springfield, MO||St. John's Clinic||no longer recruiting|
|Omaha, NE||Methodist Cancer Center||no longer recruiting|
|Denville, NJ||St. Clare's Hospital Oncology and Hematology||no longer recruiting|
|Morristown, NJ||Hematology Oncology Associates of Northern NJ||no longer recruiting|
|Vineland, NJ||Southern Oncology and Hematology||no longer recruiting|
|Albuquerque, NM||New Mexico Oncology Hematology Consultants||no longer recruiting|
|Burlington, NC||Alamance Regional Medical Center||no longer recruiting|
|Cincinnati, OH||Oncology Hematology Care||no longer recruiting|
|Columbus, OH||Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center||no longer recruiting|
|Elyria, OH||Hematology/Oncology Inc||no longer recruiting|
|Sylvania, OH||Hickman Cancer Center (Flower Hospital)||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Medical Center||no longer recruiting|
|Rockledge, PA||Bux-Mont Oncology, Fox Chase Cancer Center||no longer recruiting|
|Charleston, SC||Medical University of South Carolina||no longer recruiting|
|Columbia, SC||South Carolina Oncology Associates, PA||no longer recruiting|
|Mt. Pleasant, SC||Lowcountry Hematology Oncology||no longer recruiting|
|Myrtle Beach, SC||Coastal Cancer Center||no longer recruiting|
|Spartanburg, SC||Spartanburg Regional Medical Center||no longer recruiting|
|Chattanooga, TN||Associates in Hematology Oncology||no longer recruiting|
|Chattanooga, TN||Chattanooga Oncology Hematology Associates||no longer recruiting|
|Collierville, TN||Family Cancer Center||no longer recruiting|
|Nashville, TN||Tennessee Oncology, PLLC||no longer recruiting|
|Corpus Christi, TX||Coastal Bend Cancer Center||no longer recruiting|
|Ft. Worth, TX||Center for Cancer and Blood Disorders||no longer recruiting|
|Houston, TX||Medical Oncology Methodist Hospital||no longer recruiting|
|San Antonio, TX||South Texas Oncology and Hematology||no longer recruiting|
|Newport News, VA||Peninsula Cancer Institute||no longer recruiting|
|Richmond, VA||Virginia Cancer Institute||no longer recruiting|
|San Juan, Puerto Rico||San Juan Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Disease Free Survival
time frame: 5.25 years
time frame: 5.25 years
Number of treatment-emergent adverse events as a measure of safety.
time frame: evry 21 days for duration of treatment
Female participants at least 18 years old.
- Female patients greater than or equal to18 years of age.
- Histologically confirmed invasive unilateral breast cancer (regardless of histology).
- 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).
- 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.
- Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.
- 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.
- 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).
- Estrogen receptor negative (<10% staining by IHC for estrogen receptor).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Patient must be <= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy).
- 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.
- Adequate hematologic function, defined by:
- Absolute neutrophil count (ANC) >1500/mm3
- Platelet count >=100,000/mm3
- Hemoglobin >9 g/dL
- 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).
- Adequate renal function, defined by:
- Serum creatinine <=1.5 x ULN
- 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.
- 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).
- 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).
- 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.
- 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.
- Patient must be accessible for treatment and follow-up.
- 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.
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
- Women who are pregnant or breastfeeding.
- 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.
- Any evidence or suspicion of metastatic disease other than ipsilateral axillary lymph nodes.
- Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).
- Previous anthracycline chemotherapy.
- Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of study treatment until the end of treatment with ixabepilone.
- Previous treatment for this breast cancer (including neoadjuvant chemotherapy).
- 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).
- Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0.
- 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.
- History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or a drug formulated in CremophorEL such as paclitaxel.
- Use of any investigational agent within 30 days of administration of the first dose of study drug.
- Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- 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.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Inability to comply with study and/or follow-up procedures.
|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|
|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.|
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