Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer
A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
1 other identifier
interventional
55
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Apr 2002
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedMarch 24, 2015
October 1, 2014
2.7 years
September 6, 2005
March 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.
2 years
Interventions
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.
Eligibility Criteria
You may qualify if:
- Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Craig A. Bunnell, MD, MPHlead
- Dana-Farber Cancer Institutecollaborator
- Massachusetts General Hospitalcollaborator
- Brigham and Women's Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Pharmaciacollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Center
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig Bunnell, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Chief Medical Officer
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 7, 2005
Study Start
April 1, 2002
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
March 24, 2015
Record last verified: 2014-10