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



Status:Completed
Conditions:Breast Cancer, Cancer, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - 120
Updated:4/21/2016
Start Date:February 1997

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.

PURPOSE: This clinical trial is studying the effect of chemotherapy on heart function in
treating women who have breast cancer with negative axillary lymph nodes and who are
undergoing treatment on 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
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