A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer
TITAN
Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer
2 other identifiers
interventional
614
2 countries
70
Brief Summary
This is a randomized, Phase III, open-label, multicenter study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Dec 2008
Typical duration for phase_3 breast-cancer
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
April 12, 2017
CompletedJuly 2, 2017
June 1, 2017
7 years
November 11, 2008
November 7, 2016
June 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival
The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.
up to 5.25 years (63 months)
Secondary Outcomes (1)
Overall Survival
up to 5.25 years (63 months)
Study Arms (2)
Doxorubicin/cyclophosphamide, ixabepilone
EXPERIMENTALDoxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.
Doxorubicin/cyclophosphamide, paclitaxel
ACTIVE COMPARATORDoxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.
Interventions
Doxorubicin 60 mg/m2
Cyclophosphamide 600 mg/m2
Ixabepilone 40 mg/m2
Paclitaxel 80 mg/m2
Eligibility Criteria
You may qualify if:
- 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:
- +39 more criteria
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Bristol-Myers Squibbcollaborator
Study Sites (70)
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207, United States
Cancer Center of Huntsville
Huntsville, Alabama, 35801, United States
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
University of Southern Alabama
Mobile, Alabama, 36604, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Wilshire Oncology Medical Group
La Verne, California, 91750, United States
New Hope Cancer and Research Institute
Pomona, California, 91767, United States
Eastern Connecticut Hematology Oncology
Norwich, Connecticut, 06360, United States
Aventura Medical Center
Aventura, Florida, 33180, United States
Lynn Cancer Institute
Boca Raton, Florida, 33428, United States
Florida Cancer Care
Davie, Florida, 33328, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Memorial Regional Cancer Center
Hollywood, Florida, 33021, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Space Coast Medical Associates
Titusville, Florida, 32796, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Emory/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Augusta Oncology Associates
Augusta, Georgia, 30901, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Medical College of Georgia Cancer Specialists
Augusta, Georgia, 30912, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Suburban Hem Onc
Lawrenceville, Georgia, 30045, United States
Mid-Illinois Hematology & Oncology
Normal, Illinois, 61761, United States
Hematology Oncology of the North Shore
Skokie, Illinois, 60076, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260, United States
Providence Medical Group
Terre Haute, Indiana, 47802, United States
Kansas City Cancer Centers
Overland Park, Kansas, 66210, United States
Cotton O'Neil Cancer Center
Topeka, Kansas, 66606, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Mercy Hospital
Portland, Maine, 04101, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Fallon Clinic
Worcester, Massachusetts, 01608, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Fairview Medical Oncology Clinic
Edina, Minnesota, 55436, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
St. John's Clinic
Springfield, Missouri, 65804, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
St. Clare's Hospital Oncology and Hematology
Denville, New Jersey, 07834, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07960, United States
Southern Oncology and Hematology
Vineland, New Jersey, 08360, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
Alamance Regional Medical Center
Burlington, North Carolina, 27215, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center
Columbus, Ohio, 43219, United States
Hematology/Oncology Inc
Elyria, Ohio, 44035, United States
Hickman Cancer Center (Flower Hospital)
Sylvania, Ohio, 43560, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Bux-Mont Oncology, Fox Chase Cancer Center
Rockledge, Pennsylvania, 18960, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Lowcountry Hematology Oncology
Mt. Pleasant, South Carolina, 29464, United States
Coastal Cancer Center
Myrtle Beach, South Carolina, 29572, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Associates in Hematology Oncology
Chattanooga, Tennessee, 37404, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Family Cancer Center
Collierville, Tennessee, 38017, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 78463, United States
Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Medical Oncology Methodist Hospital
Houston, Texas, 77030, United States
South Texas Oncology and Hematology
San Antonio, Texas, 78258, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Virginia Cancer Institute
Richmond, Virginia, 23235, United States
San Juan Hospital
San Juan, Puerto Rico
Related Publications (1)
Yardley DA, Arrowsmith ER, Daniel BR, Eakle J, Brufsky A, Drosick DR, Kudrik F, Bosserman LD, Keaton MR, Goble SA, Bubis JA, Priego VM, Pendergrass K, Manalo Y, Bury M, Gravenor DS, Rodriguez GI, Inhorn RC, Young RR, Harwin WN, Silver C, Hainsworth JD, Burris HA 3rd. TITAN: phase III study of doxorubicin/cyclophosphamide followed by ixabepilone or paclitaxel in early-stage triple-negative breast cancer. Breast Cancer Res Treat. 2017 Aug;164(3):649-658. doi: 10.1007/s10549-017-4285-6. Epub 2017 May 15.
PMID: 28508185BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles H. Davis, RAC
- Organization
- Sarah Cannon Development Innovations
Study Officials
- STUDY CHAIR
Denise A Yardley, M.D.
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2008
First Posted
November 13, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2015
Study Completion
November 1, 2016
Last Updated
July 2, 2017
Results First Posted
April 12, 2017
Record last verified: 2017-06