Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Upon determination of eligibility, patients will be receive both induction neo-adjuvant
regimen and a postoperative adjuvant regimen:
Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim
Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim
Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an
aromatase inhibitor at physician discretion.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response
18 months
No
Denise A. Yardley, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Institutional Review Board
SCRI BRE 73
NCT00193206
September 2005
May 2009
Name | Location |
---|---|
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Mercy Hospital | Portland, Maine 04101 |
Chattanooga Oncology and Hematology Associates | Chattanooga, Tennessee 37404 |
Hematology Oncology Life Center | Alexandria, Louisiana 71301 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Watson Clinic Center for Cancer Care and Research | Lakeland, Florida 33805 |