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.
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
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There are 48 Locations for this study
Palm Springs California, 92262, United States
Coral Spring Florida, 33065, United States
Davie Florida, 33328, United States
Lake Worth Florida, 33467, United States
Tampa Florida, 33612, United States
Louisville Kentucky, 40202, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10461, United States
Seattle Washington, 98101, United States
Spokane Washington, 99204, United States
Capital Federal Buenos Aires, 1417, Argentina
Capital Federal Buenos Aires, 1425, Argentina
Buenos Aires , 1180A, Argentina
Buenos Aires , 1650, Argentina
Salzburg , 5020, Austria
Vienna , 1090, Austria
Wien , 1090, Austria
Bordeaux , 33000, France
Saint Herblain , 44805, France
Duesseldorf , 40235, Germany
Erlangen , 91054, Germany
Jena , 07743, Germany
New Delhi Delhi, 110 0, India
Bangalore Karnataka, 56002, India
Trivandrum Kerala, 69501, India
Pune Maharashtra, 41100, India
Bhopal , 46200, India
Hyderabad , 500 0, India
Mumbai , 40001, India
Vellore , 63200, India
Bologna , 40138, Italy
Seoul , 135-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Callao , 2, Peru
Lima , 34, Peru
Lima , LIMA , Peru
Cebu City , 6000, Philippines
Davao City , 8000, Philippines
Quezon City , 1114, Philippines
Kazan , 42002, Russian Federation
Moscow , 12912, Russian Federation
St Petersburg , 19702, Russian Federation
Singapore , 30843, Singapore
Barcelona , 08035, Spain
Jaen , 23007, Spain
Lleida , 25198, Spain
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Nottingham Nottinghamshire, NG5 1, United Kingdom
Coventry Warwickshire, CV22D, United Kingdom
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