Status:
COMPLETED
Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer
Lead Sponsor:
Craig A. Bunnell, MD, MPH
Collaborating Sponsors:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Conditions:
Breast Cancer
Stage I Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.
Detailed Description
* Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment. * Patients will receive cytoxan (cyclophosphamide) and epirubicin intrav...
Eligibility Criteria
Inclusion
- Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
- 18 years of age or older
- ANC \> 1,000/mm3
- Platelet count \> 100,000/mm3
- Hemoglobin \> 10
- Creatinine \< 2.0
- SGOT \< 2 x ULN
- Bilirubin \< 1.5mg/dl
- Able to swallow and retain oral medication
- LVEF greater than or equal to 50%
- ECOG performance status of 0 or 1
Exclusion
- Pregnant or lactating
- Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
- Prior chemotherapy within 5 years
- Prior anthracycline therapy
- Serious comorbid physical or psychological condition
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00146588
Start Date
April 1 2002
End Date
December 1 2004
Last Update
March 24 2015
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115