Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: To be included in this study, you must meet the following criteria: Adenocarcinoma of the breast confirmed by biopsy Female Patients >18 years of age Normal cardiac function Ability to perform activities of daily living with minimal assistance Chemotherapy naïve or have received prior chemotherapy > 5 years ago Adequate bone marrow, liver and kidney function Be informed of the investigational nature of this study Sign an informed consent form Sentinel lymph node and/or axillary dissection prior to enrollment Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Life expectancy of < than 6 months History of significant heart disease Prior chemotherapy or hormonal therapy Concurrent Trastuzumab therapy History of significant psychiatric disorders 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
Arms of the Study
Arm 1
Experimental
Intervention
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.