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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Achieving Pathologic Complete Response (pCR)
The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.
at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA163-100
NCT00455533
October 2007
December 2009
Name | Location |
---|---|
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Comprehensive Cancer Center | Glendale, California 91204 |
Albert Einstein Cancer Center | Bronx, New York 10461 |
Moffitt Cancer Center | Tampa, Florida 33612 |
Florida Cancer Research Institute | Davie, Florida |
Northwest Oncology & Hematology Associates | Coral Spring, Florida 33065 |
Medical Specialists Of Palm Beaches | Lake Worth, Florida 33467 |
University Medical Center, Inc | Louisville, Kentucky 40202 |
Providence Cancer Center | Spokane, Washington 99204 |