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
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Breast Cancer |
Intervention | Drug: Ixabepilone Drug: Paclitaxel Drug: Cyclophosphamide Drug: Doxorubicin |
Phase | Phase 2 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00455533 |
First Received | April 2, 2007 |
Last Updated | May 25, 2011 |
Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | April 2, 2007 |
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Last Updated Date | May 25, 2011 |
Start Date | October 2007 |
Estimated Primary Completion Date | December 2009 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
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 |
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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 |
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 | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | Drug: Ixabepilone Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks Other Names:
Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks Drug: Cyclophosphamide Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks Drug: Doxorubicin Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 384 |
Estimated Completion Date | December 2009 |
Estimated Primary Completion Date | December 2009 |
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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Argentina, Austria, France, Germany, India, Italy, Korea, Republic of, Peru, Philippines, Russian Federation, Singapore, Spain, Taiwan, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00455533 |
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Other Study ID Numbers | CA163-100 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | May 2011 |
Locations[ + expand ][ + ]
Comprehensive Cancer Center | Palm Springs, California, United States, 92262 |
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Northwest Oncology & Hematology Associates | Coral Spring, Florida, United States, 33065 |
Florida Cancer Research Institute | Davie, Florida, United States, 33328 |
Medical Specialists Of Palm Beaches | Lake Worth, Florida, United States, 33467 |
Moffitt Cancer Center | Tampa, Florida, United States, 33612 |
University Medical Center, Inc | Louisville, Kentucky, United States, 40202 |
University Of New Mexico Cancer Center | Albuquerque, New Mexico, United States, 87131 |
Albert Einstein Cancer Center | Bronx, New York, United States, 10461 |
Virginia Mason Medical Center | Seattle, Washington, United States, 98101 |
Providence Cancer Center | Spokane, Washington, United States, 99204 |
Local Institution | Capital Federal, Buenos Aires, Argentina, 1425 |
Local Institution | Capital Federal, Buenos Aires, Argentina, 1417 |
Local Institution | Buenos Aires, Argentina, 1180AAX |
Local Institution | Buenos Aires, Argentina, 1650 |
Local Institution | Salzburg, Austria, 5020 |
Local Institution | Vienna, Austria, 1090 |
Local Institution | Wien, Austria, 1090 |
Local Institution | Bordeaux, France, 33000 |
Local Institution | Saint Herblain, France, 44805 |
Local Institution | Duesseldorf, Germany, 40235 |
Local Institution | Erlangen, Germany, 91054 |
Local Institution | Jena, Germany, 07743 |
Local Institution | New Delhi, Delhi, India, 110 095 |
Local Institution | Bangalore, Karnataka, India, 560029 |
Local Institution | Trivandrum, Kerala, India, 695011 |
Local Institution | Pune, Maharashtra, India, 411001 |
Local Institution | Bhopal, India, 462001 |
Local Institution | Hyderabad, India, 500 004 |
Local Institution | Mumbai, India, 400012 |
Local Institution | Vellore, India, 632004 |
Local Institution | Bologna, Italy, 40138 |
Local Institution | Seoul, Korea, Republic of, 135-710 |
Local Institution | Seoul, Korea, Republic of, 135-720 |
Local Institution | Callao, Peru, 2 |
Local Institution | Lima, Peru, LIMA 11 |
Local Institution | Lima, Peru, 34 |
Local Institution | Cebu City, Philippines, 6000 |
Local Institution | Davao City, Philippines, 8000 |
Local Institution | Quezon City, Philippines, 1114 |
Local Institution | Kazan, Russian Federation, 420029 |
Local Institution | Moscow, Russian Federation, 129128 |
Local Institution | St Petersburg, Russian Federation, 197022 |
Local Institution | Singapore, Singapore, 308433 |
Local Institution | Barcelona, Spain, 08035 |
Local Institution | Jaen, Spain, 23007 |
Local Institution | Lleida, Spain, 25198 |
Local Institution | Taipei, Taiwan, 11217 |
Local Institution | Taipei, Taiwan, 100 |
Local Institution | Nottingham, Nottinghamshire, United Kingdom, NG5 1PB |
Local Institution | Coventry, Warwickshire, United Kingdom, CV22DX |