Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 cyclophospham...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00455533
Start Date
October 1 2007
End Date
December 1 2009
Last Update
February 24 2016
Active Locations (49)
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1
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
2
Northwest Oncology & Hematology Associates
Coral Spring, Florida, United States, 33065
3
Florida Cancer Research Institute
Davie, Florida, United States, 33328
4
Medical Specialists Of Palm Beaches
Lake Worth, Florida, United States, 33467