Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Locally Advanced Breast Cancer, Inflammatory Breast Cancer, Breast Cancer, Abraxane, nab Paclitaxel, Epirubicin, Gemcitabine, Gemzar
Eligibility Criteria
Inclusion Criteria: To be included in this study, you must meet the following criteria: Locally advanced/inflammatory adenocarcinoma of the breast 18 years of age or older Normal heart function Able to perform activities of daily living with minimal assistance No prior chemotherapy for breast cancer Adequate bone marrow, liver and kidney function No evidence or history of significant cardiovascular abnormalities Sentinel node or axillary dissection Sign an informed consent form Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Pregnant or breast feeding History of heart disease with congestive heart failure Heart attack within the previous 6 months Prior chemotherapy or hormone therapy for breast cancer History of active uncontrolled infection Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Sites / Locations
- Florida Cancer Specialists
- Integrated Community Oncology Network
- Watson Clinic Center for Cancer Care and Research
- Florida Hospital Cancer Institute
- Northeast Georgia Medical Center
- Consultants in Blood Disorders and Cancer
- Hematology Oncology Life Center
- Mercy Hospital
- Oncology Hematology Care
- Spartanburg Regional Medical Center
- Chattanooga Oncology and Hematology Associates
- Tennessee Oncology
- Peninsula Cancer Institute
Arms of the Study
Arm 1
Experimental
Intervention
Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.