A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer
OBJECTIVES: I. Determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and
epirubicin in women with locally advanced or inflammatory or large operable breast cancer.
II. Determine the maximum tolerated dose of this regimen in this patient population.
OUTLINE: This is a multicenter dose escalation study of capecitabine. Patients receive
neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily
on days 1-14. Treatment continues every 21 days for a maximum of 6 courses in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
PROJECTED ACCRUAL: A total of 3-33 patients will be accrued for this study.
Primary Purpose: Treatment
Herve Bonnefoi, MD
Hopital Cantonal Universitaire de Geneve
United States: Federal Government