Trial Information

Randomized Phase II Trial of Irinotecan (CPT-11) In Patients With Refractory Metastatic Breast Cancer

OBJECTIVES: I. Assess the antitumor activity and toxicity of two different schedules of
irinotecan in the treatment of patients with refractory metastatic breast cancer who have
received 1 or 2 previous chemotherapy regimens (up to one prior therapy for metastatic
disease and one for adjuvant therapy). II. Compare the time to progression, survival, and
quality of life of these patients on these 2 different schedules of irinotecan.

OUTLINE: This is a randomized study. Patients are stratified according to dominant disease
(visceral vs nonvisceral), performance status (0-1 vs 2), and prior chemotherapy in
metastatic setting (yes vs no). Patients assigned to arm I receive irinotecan intravenously
over 90 minutes every week for 4 weeks followed by a 2 week rest period. Treatment is
repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients assigned to arm II receive irinotecan intravenously over 90 minutes every 3 weeks
for 6 weeks. Treatment is repeated every 6 weeks in the absence of disease progression or
unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are
followed every 3 months for 2 years, then annually for 1 year.

PROJECTED ACCRUAL: A total of 42-100 patients (21-50 patients per arm) will be accrued for
this study within 3.5 years.