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Study 1 of 6485 for search of: | United States, Ohio |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002900 |
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.
Condition | Intervention |
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Breast Cancer Cancer-Related Problem/Condition |
Procedure: management of therapy complications |
Study Type: | Observational |
Official Title: | A STUDY OF THE LATE CARDIAC EFFECTS OF TWO DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENTS IN WOMEN WITH NODE NEGATIVE BREAST CANCER TREATED ON SWOG-8897 |
Estimated Enrollment: | 420 |
Study Start Date: | February 1997 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Patricia A. Ganz, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000065237, SWOG-9342 |
Study First Received: | November 1, 1999 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00002900 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer ductal breast carcinoma cardiac toxicity |
Skin Diseases Breast Neoplasms Carcinoma, Ductal, Breast Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site |