Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
NCT ID: NCT00455533
Last Updated: 2016-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
384 participants
INTERVENTIONAL
2007-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Ixabepilone
Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks
Cyclophosphamide
Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks
Doxorubicin
Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks
B
Paclitaxel
Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks
Cyclophosphamide
Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks
Doxorubicin
Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks
Interventions
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Ixabepilone
Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks
Paclitaxel
Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks
Cyclophosphamide
Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks
Doxorubicin
Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status
* No prior treatment for breast cancer excluding therapy for DCIS
* Karnofsky performance status of 80 - 100
* left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated acquisition (MUGA)
* Adequate hematologic, hepatic and renal function
Exclusion Criteria
* Women who are pregnant or breastfeeding
* Inflammatory or metastatic breast cancer
* Unfit for breast and/or axillary surgery
* Evidence of baseline sensory or motor neuropathy
* Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection
* History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL
18 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Comprehensive Cancer Center
Palm Springs, California, United States
Northwest Oncology & Hematology Associates
Coral Spring, Florida, United States
Florida Cancer Research Institute
Davie, Florida, United States
Medical Specialists Of Palm Beaches
Lake Worth, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University Medical Center, Inc
Louisville, Kentucky, United States
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Albert Einstein Cancer Center
The Bronx, New York, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Providence Cancer Center
Spokane, Washington, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Salzburg, , Austria
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Vienna, , Austria
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Bordeaux, , France
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Saint-Herblain, , France
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Düsseldorf, , Germany
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Erlangen, , Germany
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Jena, , Germany
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Bangalore, Karnataka, India
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Trivandrum, Kerala, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Bhopal, , India
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Hyderabad, , India
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Mumbai, , India
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Vellore, , India
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Bologna, , Italy
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Callao, Provincia Constitucional del Callao, Peru
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Cebu City, , Philippines
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Davao City, , Philippines
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Quezon City, , Philippines
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Jaén, , Spain
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Lleida, , Spain
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Taipei, , Taiwan
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Taipei, , Taiwan
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Nottingham, Nottinghamshire, United Kingdom
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Coventry, Warwickshire, United Kingdom
Countries
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References
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Abdel-Fatah TMA, Agarwal D, Liu DX, Russell R, Rueda OM, Liu K, Xu B, Moseley PM, Green AR, Pockley AG, Rees RC, Caldas C, Ellis IO, Ball GR, Chan SYT. SPAG5 as a prognostic biomarker and chemotherapy sensitivity predictor in breast cancer: a retrospective, integrated genomic, transcriptomic, and protein analysis. Lancet Oncol. 2016 Jul;17(7):1004-1018. doi: 10.1016/S1470-2045(16)00174-1. Epub 2016 Jun 14.
Related Links
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Investigator Inquiry form
Other Identifiers
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EUDRACT 2006-003047-24
Identifier Type: -
Identifier Source: secondary_id
CA163-100
Identifier Type: -
Identifier Source: org_study_id
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