Trial Information

A STUDY OF THE LATE CARDIAC EFFECTS OF TWO DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENTS IN WOMEN WITH NODE NEGATIVE BREAST CANCER TREATED ON SWOG-8897

OBJECTIVES:

- Compare the frequency of subclinical congestive heart failure by measuring resting MUGA
at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy
with cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, doxorubicin,
and fluorouracil on protocol SWOG-8897.

- Estimate the frequency of late cardiac effects (congestive heart failure, cardiac
ischemic events, and clinical symptoms) in these patients treated with these regimens.

- Monitor prospectively the incidence of annual cardiac events between the fifth and
tenth year after randomization of these patients to these regimens.

OUTLINE: This is a multicenter study.

The treating physician completes patient cardiovascular and routine history and physical
examination questionnaires at baseline and yearly. Patients undergo resting MUGA scans at
5-8 and 10-11 years after registration on protocol SWOG-8897. The first scan must be
performed within 3 months prior to enrollment or within 1 month after registration on the
current study, and the second scan must be done in the tenth year of follow-up and within 3
months prior to enrollment or 1 month from the anniversary of registration on the current
study.

PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study. After initial
accrual is completed, approximately 50 additional patients will be accrued at 10 years.