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 |
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.
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.
- 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
We found this trial at
105
sites
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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2279 45th Street
Sacramento, California 95817
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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747 Broadway
Seattle, Washington 98122
Seattle, Washington 98122
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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1501 North Campbell Avenue
Tucson, Arizona 85719
Tucson, Arizona 85719
(520) 694-CURE (2873)
Arizona Cancer Center at University of Arizona Health Sciences Center Since being established in 1976,...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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Denver, Colorado 80010
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
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Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 568-3435
MBCCOP - LSU Health Sciences Center Established in 1990, the Stanley S. Scott Cancer Center...
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CCOP - Bay Area Tumor Institute he Bay Area Tumor Institute Community Clinical Oncology Program...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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