Breast Cancer Clinical Trial
Official title:
A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of
capecitabine in treating women who have advanced or metastatic breast cancer.
OBJECTIVES:
- Compare the objective response rate in women with advanced or metastatic breast cancer
treated with two dose levels of capecitabine.
- Compare the duration of response, time to progression, time to treatment failure,
survival, incidence of adverse events, and time to onset of the adverse experience in
patients treated with this drug.
- Compare the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs
no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14.
- Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, at the end of the third and sixth courses, and at
completion of therapy.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study within 9 months.
;
Primary Purpose: Treatment
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