Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

C

Craig A. Bunnell, MD, MPH

Status

Completed

Conditions

Stage IIIA Breast Cancer
Breast Cancer
Stage II Breast Cancer
Stage I Breast Cancer

Treatments

Drug: Capecitabine
Drug: Epirubicin
Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00146588
02-036

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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