Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146588
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2005-09-06
Brief Title:
Cytoxan Epirubicin and Capecitabine in Women With Breast Cancer
Sponsor:
Craig A Bunnell MD MPH
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Study of Cytoxan Epirubicin and Capecitabine in Women With Stage IIIIIIA Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IIIIIIIA 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 intravenously on day 1 of each treatment cycle On days 4-17 of each cycle patients will take capecitabine orally twice a day
While on the study patients will be required to complete a diary of they capecitabine treatment
Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patients experience with the oral chemotherapy
Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects
Patients will receive cytoxan cyclophosphamide and epirubicin intravenously on day 1 of each treatment cycle On days 4-17 of each cycle patients will take capecitabine orally twice a day
While on the study patients will be required to complete a diary of they capecitabine treatment
Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patients experience with the oral chemotherapy
Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None