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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00455533

Run by

Bristol-Myers Squibb

People needed

384

Starts

2007-10-01

Expected to finish

2009-12-01

Last updated by the study team

2016-02-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — The Bronx, New York, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Providence Cancer Center — Spokane, Washington, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Salzburg, Austria
• Local Institution — Vienna, Austria
• Local Institution — Bordeaux, France
• Local Institution — Saint-Herblain, France
• Local Institution — Düsseldorf, Germany
• Local Institution — Erlangen, Germany
• Local Institution — Jena, Germany
• Local Institution — Bangalore, Karnataka, India
• Local Institution — Trivandrum, Kerala, India
• Local Institution — Pune, Maharashtra, India
• Local Institution — New Delhi, National Capital Territory of Delhi, India

Full record on ClinicalTrials.gov

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