Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients|
- Pathologic Complete Response (pCR) [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
- Time to Treatment Failure (TTF) [ Time Frame: 69 months ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
Other Name: GemzarDrug: Epirubicin
Other Name: EllenceDrug: Docetaxel
Other Name: Taxotere
Upon determination of eligibility, all patients will be receive:
Gemcitabine + Epirubicin + Docetaxel
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193050
|Principal Investigator:||Denise A. Yardley, MD||SCRI Development Innovations, LLC|