Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.
|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|