Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00193050|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : September 21, 2012
Last Update Posted : September 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Gemcitabine Drug: Epirubicin Drug: Docetaxel||Phase 2|
Upon determination of eligibility, all patients will be receive:
Gemcitabine + Epirubicin + Docetaxel
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2009|
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
- Pathologic Complete Response (pCR) [ Time Frame: 18 Months ]
- Time to Treatment Failure (TTF) [ Time Frame: 69 months ]
- Overall Survival (OS) [ Time Frame: 48 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193050
|Principal Investigator:||Denise A. Yardley, MD||SCRI Development Innovations, LLC|