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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Drug: Cyclophosphamide Drug: Epirubicin Drug: Capecitabine

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 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
Study Start Date : April 2002
Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Craig A. Bunnell, MD, MPH
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Principal Investigator: Craig Bunnell, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Craig A. Bunnell, MD, MPH, Associate Chief Medical Officer, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00146588     History of Changes
Other Study ID Numbers: 02-036
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: October 2014

Keywords provided by Craig A. Bunnell, MD, MPH, Dana-Farber Cancer Institute:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors