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



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

For Condition: ductal breast carcinoma,stage 2 breast cancer,cardiac toxicity,stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PatriciaGanz,  Study Chair,  Jonsson Comprehensive Cancer Center

Loyola University Medical Center
Maywood,  Illinois,  60153-5500
United States
 

Veterans Affairs Medical Center - Amarillo
Amarillo,  Texas,  79106
United States
 

Dwight David Eisenhower Army Medical Center
Fort Gordon,  Georgia,  30905-5650
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

Veterans Affairs Medical Center - Detroit
Detroit,  Michigan,  48201-1932
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78229-3900
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Veterans Affairs Medical Center - Salt Lake City
Salt Lake City,  Utah,  84148
United States
 

Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson,  Arizona,  85724
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

CCOP - Western Regional, Arizona
Phoenix,  Arizona,  85006-2726
United States
 

Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago,  Illinois,  60612
United States
 

University of Michigan Comprehensive Cancer Center
Ann Arbor,  Michigan,  48109-0912
United States
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195-9001
United States
 

MBCCOP - Hawaii
Honolulu,  Hawaii,  96813
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

University of California Davis Cancer Center
Sacramento,  California,  95817
United States
 

CCOP - Atlanta Regional
Atlanta,  Georgia,  30342-1701
United States
 

Veterans Affairs Medical Center - Oklahoma City
Oklahoma City,  Oklahoma,  73104
United States
 

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle,  Washington,  98104
United States
 

Veterans Affairs Medical Center - Biloxi
Biloxi,  Mississippi,  39531-2410
United States
 

Fletcher Allen Health Care - University Health Center Campus
Burlington,  Vermont,  05401
United States
 

Veterans Affairs Medical Center - Houston
Houston,  Texas,  77030
United States
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

Veterans Affairs Medical Center - Portland
Portland,  Oregon,  97207
United States
 

Veterans Affairs Medical Center - Albuquerque
Albuquerque,  New Mexico,  87108-5138
United States
 

University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver,  Colorado,  80010
United States
 

Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain,  Massachusetts,  02130
United States
 

Brooke Army Medical Center
Fort Sam Houston,  Texas,  78234-6200
United States
 

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

UCSF Comprehensive Cancer Center
San Francisco,  California,  94143-0128
United States
 

Louisiana State University Health Sciences Center - Shreveport
Shreveport,  Louisiana,  71130-3932
United States
 

Veterans Affairs Medical Center - Denver
Denver,  Colorado,  80220
United States
 

CCOP - Toledo Community Hospital
Toledo,  Ohio,  43623-3456
United States
 

CCOP - Dayton
Dayton,  Ohio,  45429
United States
 

Tulane University School of Medicine
New Orleans,  Louisiana,  70112
United States
 

CCOP - Northwest
Tacoma,  Washington,  98405-0986
United States
 

Veterans Affairs Medical Center - Kansas City
Kansas City,  Missouri,  64128
United States
 

Cancer Research Center of Hawaii
Honolulu,  Hawaii,  96813-2424
United States
 

Veterans Affairs Medical Center - Long Beach
Long Beach,  California,  90822
United States
 

Veterans Affairs Medical Center - Ann Arbor
Ann Arbor,  Michigan,  48105
United States
 

Veterans Affairs Medical Center - Jackson
Jackson,  Mississippi,  39216
United States
 

MBCCOP - University of New Mexico HSC
Albuquerque,  New Mexico,  87131
United States
 

CCOP - Santa Rosa Memorial Hospital
Santa Rosa,  California,  95403
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

Oregon Cancer Institute
Portland,  Oregon,  97201-3098
United States
 

MBCCOP - Howard University Cancer Center
Washington D.C.,  District of Columbia,  20060
United States
 

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines,  Illinois,  60141
United States
 

University of Tennessee Cancer Institute
Memphis,  Tennessee,  38103
United States
 

Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock,  Arkansas,  72205
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612-7323
United States
 

MBCCOP - Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 

Veterans Affairs Medical Center - Shreveport
Shreveport,  Louisiana,  71130
United States
 

CCOP - Michigan Cancer Research Consortium
Ann Arbor,  Michigan,  48106
United States
 

CCOP - St. Louis-Cape Girardeau
St. Louis,  Missouri,  63141
United States
 

St. Louis University Health Sciences Center
St. Louis,  Missouri,  63110
United States
 

Madigan Army Medical Center
Tacoma,  Washington,  98431-5000
United States
 

David Grant Medical Center
Travis Air Force Base,  California,  94535
United States
 

University of Kansas Medical Center
Kansas City,  Kansas,  66160-7353
United States
 

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles,  California,  90033-0804
United States
 

CCOP - Beaumont
Royal Oak,  Michigan,  48073-6769
United States
 

Barrett Cancer Center
Cincinnati,  Ohio,  45267-0501
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix,  Arizona,  85012
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Veterans Affairs Outpatient Clinic - Martinez
Martinez,  California,  94553
United States
 

CCOP - Columbia River Oncology Program
Portland,  Oregon,  97225
United States
 

Herbert Irving Comprehensive Cancer Center at Columbia University
New York City,  New York,  10032
United States
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0565
United States
 

CCOP - Virginia Mason Research Center
Seattle,  Washington,  98101
United States
 

Veterans Affairs Medical Center - Tucson
Tucson,  Arizona,  85723
United States
 

Veterans Affairs Medical Center - West Los Angeles
Los Angeles,  California,  90073
United States
 

Veterans Affairs Medical Center - Seattle
Seattle,  Washington,  98108
United States
 

Veterans Affairs Medical Center - Dallas
Dallas,  Texas,  75216
United States
 

MBCCOP - LSU Health Sciences Center
New Orleans,  Louisiana,  70112
United States
 

Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio,  Texas,  78229
United States
 

Veterans Affairs Medical Center - Albany
Albany,  New York,  12208
United States
 

Veterans Affairs Medical Center - Cincinnati
Cincinnati,  Ohio,  45220-2288
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201-1379
United States
 

University of Oklahoma Health Sciences Center
Oklahoma City,  Oklahoma,  73104
United States
 

Veterans Affairs Medical Center - Lexington
Lexington,  Kentucky,  40502-2236
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010
United States
 

Harrington Cancer Center
Amarillo,  Texas,  79106
United States
 

CCOP - Grand Rapids
Grand Rapids,  Michigan,  49503
United States
 

Danville Radiation Therapy Center
Memphis,  Tennessee,  38104
United States
 

CCOP - Bay Area Tumor Institute
Oakland,  California,  94609-3305
United States
 

Veterans Affairs Medical Center - Wichita
Wichita,  Kansas,  67218
United States
 

Providence Hospital - Southfield
Southfield,  Michigan,  48075-9975
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112-5550
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

Tripler Army Medical Center
Honolulu,  Hawaii,  96859-5000
United States
 

Hollings Cancer Center at Medical University of South Carolina
Charleston,  South Carolina,  29425
United States
 

MBCCOP - Gulf Coast
Mobile,  Alabama,  36688
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

Veterans Affairs Medical Center - Dayton
Dayton,  Ohio,  45428
United States
 

Veterans Affairs Medical Center - Temple
Temple,  Texas,  76504
United States
 

Veterans Affairs Medical Center - Charleston
Charleston,  South Carolina,  29401-5799
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065237;  SWOG-9342
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002900

Other Stage 2 Breast Cancer Studies:
1. Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

2. Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

3. Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer

4. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer

5. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery

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