Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00146588|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer||Drug: Cyclophosphamide Drug: Epirubicin Drug: Capecitabine||Not Applicable|
- 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 patient's 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
- Drug: Cyclophosphamide
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.Other Name: Cytoxan
- Drug: Epirubicin
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
- Drug: Capecitabine
Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.
- To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer. [ Time Frame: 2 years ]
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): NCT00146588
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Center|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Craig Bunnell, MD||Dana-Farber Cancer Institute|