Breast Cancer Clinical Trial

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

Summary

The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria

Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of ≥ 2 cm
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 of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

384

Study ID:

NCT00455533

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 48 Locations for this study

See Locations Near You

Comprehensive Cancer Center
Palm Springs California, 92262, United States
Northwest Oncology & Hematology Associates
Coral Spring Florida, 33065, United States
Florida Cancer Research Institute
Davie Florida, 33328, United States
Medical Specialists Of Palm Beaches
Lake Worth Florida, 33467, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University Medical Center, Inc
Louisville Kentucky, 40202, United States
University Of New Mexico Cancer Center
Albuquerque New Mexico, 87131, United States
Albert Einstein Cancer Center
Bronx New York, 10461, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Providence Cancer Center
Spokane Washington, 99204, United States
Local Institution
Capital Federal Buenos Aires, 1417, Argentina
Local Institution
Capital Federal Buenos Aires, 1425, Argentina
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Buenos Aires , 1180A, Argentina
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Buenos Aires , 1650, Argentina
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Salzburg , 5020, Austria
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Vienna , 1090, Austria
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Wien , 1090, Austria
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Bordeaux , 33000, France
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Saint Herblain , 44805, France
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Duesseldorf , 40235, Germany
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Erlangen , 91054, Germany
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Jena , 07743, Germany
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New Delhi Delhi, 110 0, India
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Bangalore Karnataka, 56002, India
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Trivandrum Kerala, 69501, India
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Pune Maharashtra, 41100, India
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Bhopal , 46200, India
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Hyderabad , 500 0, India
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Mumbai , 40001, India
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Vellore , 63200, India
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Bologna , 40138, Italy
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Seoul , 135-7, Korea, Republic of
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Seoul , 135-7, Korea, Republic of
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Callao , 2, Peru
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Lima , 34, Peru
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Lima , LIMA , Peru
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Cebu City , 6000, Philippines
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Davao City , 8000, Philippines
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Quezon City , 1114, Philippines
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Kazan , 42002, Russian Federation
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Moscow , 12912, Russian Federation
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St Petersburg , 19702, Russian Federation
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Singapore , 30843, Singapore
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Barcelona , 08035, Spain
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Jaen , 23007, Spain
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Lleida , 25198, Spain
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Taipei , 100, Taiwan
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Taipei , 11217, Taiwan
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Nottingham Nottinghamshire, NG5 1, United Kingdom
Local Institution
Coventry Warwickshire, CV22D, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

384

Study ID:

NCT00455533

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

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