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Brief Title: 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
Official Title: A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer
Study ID: NCT00455533
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, Bronx, New York, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Providence Cancer Center, Spokane, Washington, United States
Local Institution, Capital Federal, Buenos Aires, Argentina
Local Institution, Capital Federal, Buenos Aires, Argentina
Local Institution, Buenos Aires, , Argentina
Local Institution, Buenos Aires, , Argentina
Local Institution, Salzburg, , Austria
Local Institution, Vienna, , Austria
Local Institution, Wien, , Austria
Local Institution, Bordeaux, , France
Local Institution, Saint Herblain, , France
Local Institution, Duesseldorf, , Germany
Local Institution, Erlangen, , Germany
Local Institution, Jena, , Germany
Local Institution, New Delhi, Delhi, India
Local Institution, Bangalore, Karnataka, India
Local Institution, Trivandrum, Kerala, India
Local Institution, Pune, Maharashtra, India
Local Institution, Bhopal, , India
Local Institution, Hyderabad, , India
Local Institution, Mumbai, , India
Local Institution, Vellore, , India
Local Institution, Bologna, , Italy
Local Institution, Seoul, , Korea, Republic of
Local Institution, Seoul, , Korea, Republic of
Local Institution, Callao, , Peru
Local Institution, Lima, , Peru
Local Institution, Lima, , Peru
Local Institution, Cebu City, , Philippines
Local Institution, Davao City, , Philippines
Local Institution, Quezon City, , Philippines
Local Institution, Kazan, , Russian Federation
Local Institution, Moscow, , Russian Federation
Local Institution, St Petersburg, , Russian Federation
Local Institution, Singapore, , Singapore
Local Institution, Barcelona, , Spain
Local Institution, Jaen, , Spain
Local Institution, Lleida, , Spain
Local Institution, Taipei, , Taiwan
Local Institution, Taipei, , Taiwan
Local Institution, Nottingham, Nottinghamshire, United Kingdom
Local Institution, Coventry, Warwickshire, United Kingdom
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR