SWOG-9342 Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial

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.

DISEASE CHARACTERISTICS:

- Women registered on Arm I, II, III, or IV of protocol SWOG-8897 who have completed at
least 1 course of assigned chemotherapy

- Completion of tamoxifen therapy not required

- Registration to current study required between 5.25-8 years or 10-11 years after
randomization to protocol SWOG-8897

- Patients must be diagnosed disease-free with no prior recurrence after registration
on protocol SWOG-8897

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Pre- and postmenopausal

Performance status:

- Not specified

Life Expectancy:

- At least 5 years

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Pregnant or nursing women not eligible for nuclear medicine (MUGA) portion of study

- Fertile patients must use effective contraception during and for 1 month after MUGA

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy for second primary malignancy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for second primary malignancy

Surgery:

- Not specified