Breast Cancer, Cardiac Toxicity
Conditions
Keywords
stage I breast cancer, stage II breast cancer, ductal breast carcinoma, cardiac toxicity
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREmanagement of therapy complications
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed