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CompletedNCT00002900Updated Oct 19, 2015

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

An observational study in Breast Cancer and Cardiac Toxicity, sponsored by SWOG Cancer Research Network. Completed at 105 sites in United States. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-10-19.

Sponsored by SWOG Cancer Research Network · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
180
Ages
18 Years to 120 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Cardiac Toxicity

Keywords

  • stage I breast cancer
  • stage II breast cancer
  • ductal breast carcinoma
  • cardiac toxicity
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 180 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with histologically proven invasive adenocarcinoma of the breast with negative axillary lymph nodes

Eligibility 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
05

Study design

Time perspective
Prospective
Enrollment
180 participants (actual)

Interventions

  • Proceduremanagement of therapy complications
06

Study locations

105 sites
  • MBCCOP - Gulf Coast
    Mobile, Alabama 36688, United States
  • CCOP - Western Regional, Arizona
    Phoenix, Arizona 85006-2726, United States
  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
    Phoenix, Arizona 85012, United States
  • Veterans Affairs Medical Center - Tucson
    Tucson, Arizona 85723, United States
  • Arizona Cancer Center at University of Arizona Health Sciences Center
    Tucson, Arizona 85724, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Veterans Affairs Medical Center - Little Rock (McClellan)
    Little Rock, Arkansas 72205, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Veterans Affairs Medical Center - Long Beach
    Long Beach, California 90822, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90033-0804, United States
  • Veterans Affairs Medical Center - West Los Angeles
    Los Angeles, California 90073, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
  • Veterans Affairs Outpatient Clinic - Martinez
    Martinez, California 94553, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609-3305, United States
  • Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • University of California Davis Cancer Center
    Sacramento, California 95817, United States
  • UCSF Comprehensive Cancer Center
    San Francisco, California 94143-0128, United States
  • CCOP - Santa Rosa Memorial Hospital
    Santa Rosa, California 95403, United States
  • David Grant Medical Center
    Travis Air Force Base, California 94535, United States
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    Denver, Colorado 80010, United States
  • Veterans Affairs Medical Center - Denver
    Denver, Colorado 80220, United States
  • MBCCOP - Howard University Cancer Center
    Washington, District of Columbia 20060, United States
  • CCOP - Atlanta Regional
    Atlanta, Georgia 30342-1701, United States
  • Dwight David Eisenhower Army Medical Center
    Fort Gordon, Georgia 30905-5650, United States
  • Cancer Research Center of Hawaii
    Honolulu, Hawaii 96813-2424, United States
  • MBCCOP - Hawaii
    Honolulu, Hawaii 96813, United States
  • Tripler Army Medical Center
    Honolulu, Hawaii 96859-5000, United States
  • MBCCOP - University of Illinois at Chicago
    Chicago, Illinois 60612-7323, United States
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    Chicago, Illinois 60612, United States
  • CCOP - Central Illinois
    Decatur, Illinois 62526, United States
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    Hines, Illinois 60141, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153-5500, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160-7353, United States
  • CCOP - Wichita
    Wichita, Kansas 67214-3882, United States
  • Veterans Affairs Medical Center - Wichita
    Wichita, Kansas 67218, United States
  • Veterans Affairs Medical Center - Lexington
    Lexington, Kentucky 40502-2236, United States
  • Albert B. Chandler Medical Center, University of Kentucky
    Lexington, Kentucky 40536-0084, United States
  • MBCCOP - LSU Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Tulane University School of Medicine
    New Orleans, Louisiana 70112, United States
  • Louisiana State University Health Sciences Center - Shreveport
    Shreveport, Louisiana 71130-3932, United States
  • Veterans Affairs Medical Center - Shreveport
    Shreveport, Louisiana 71130, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    Jamaica Plain, Massachusetts 02130, United States
  • Veterans Affairs Medical Center - Ann Arbor
    Ann Arbor, Michigan 48105, United States
  • CCOP - Michigan Cancer Research Consortium
    Ann Arbor, Michigan 48106, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0912, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
  • Veterans Affairs Medical Center - Detroit
    Detroit, Michigan 48201-1932, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • CCOP - Grand Rapids
    Grand Rapids, Michigan 49503, United States
  • CCOP - Beaumont
    Royal Oak, Michigan 48073-6769, United States
  • Providence Hospital - Southfield
    Southfield, Michigan 48075-9975, United States
  • CCOP - Duluth
    Duluth, Minnesota 55805, United States
  • Veterans Affairs Medical Center - Biloxi
    Biloxi, Mississippi 39531-2410, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Veterans Affairs Medical Center - Jackson
    Jackson, Mississippi 39216, United States
  • Veterans Affairs Medical Center - Kansas City
    Kansas City, Missouri 64128, United States
  • CCOP - Kansas City
    Kansas City, Missouri 64131, United States
  • St. Louis University Health Sciences Center
    Saint Louis, Missouri 63110, United States
  • CCOP - St. Louis-Cape Girardeau
    Saint Louis, Missouri 63141, United States
  • CCOP - Cancer Research for the Ozarks
    Springfield, Missouri 65807, United States
  • CCOP - Montana Cancer Consortium
    Billings, Montana 59101, United States
  • Veterans Affairs Medical Center - Albuquerque
    Albuquerque, New Mexico 87108-5138, United States
  • MBCCOP - University of New Mexico HSC
    Albuquerque, New Mexico 87131, United States
  • Veterans Affairs Medical Center - Albany
    Albany, New York 12208, United States
  • Herbert Irving Comprehensive Cancer Center at Columbia University
    New York, New York 10032, United States
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
    Rochester, New York 14642, United States
  • CCOP - Southeast Cancer Control Consortium
    Winston-Salem, North Carolina 27104-4241, United States
  • Veterans Affairs Medical Center - Cincinnati
    Cincinnati, Ohio 45220-2288, United States
  • Barrett Cancer Center
    Cincinnati, Ohio 45267-0501, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195-9001, United States
  • CCOP - Columbus
    Columbus, Ohio 43206, United States
  • Veterans Affairs Medical Center - Dayton
    Dayton, Ohio 45428, United States
  • CCOP - Dayton
    Dayton, Ohio 45429, United States
  • CCOP - Toledo Community Hospital
    Toledo, Ohio 43623-3456, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Veterans Affairs Medical Center - Oklahoma City
    Oklahoma City, Oklahoma 73104, United States
  • Oregon Cancer Institute
    Portland, Oregon 97201-3098, United States
  • Veterans Affairs Medical Center - Portland
    Portland, Oregon 97207, United States
  • CCOP - Columbia River Oncology Program
    Portland, Oregon 97225, United States
  • Veterans Affairs Medical Center - Charleston
    Charleston, South Carolina 29401-5799, United States
  • Hollings Cancer Center at Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • CCOP - Greenville
    Greenville, South Carolina 29615, United States
  • CCOP - Upstate Carolina
    Spartanburg, South Carolina 29303, United States
  • University of Tennessee Cancer Institute
    Memphis, Tennessee 38103, United States
  • Danville Radiation Therapy Center
    Memphis, Tennessee 38104, United States
  • Harrington Cancer Center
    Amarillo, Texas 79106, United States
  • Veterans Affairs Medical Center - Amarillo
    Amarillo, Texas 79106, United States
  • Veterans Affairs Medical Center - Dallas
    Dallas, Texas 75216, United States
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234-6200, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555-0565, United States
  • Veterans Affairs Medical Center - Houston
    Houston, Texas 77030, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229-3900, United States
  • Veterans Affairs Medical Center - San Antonio (Murphy)
    San Antonio, Texas 78229, United States
  • Veterans Affairs Medical Center - Temple
    Temple, Texas 76504, United States
  • CCOP - Scott and White Hospital
    Temple, Texas 76508, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112-5550, United States
  • Veterans Affairs Medical Center - Salt Lake City
    Salt Lake City, Utah 84148, United States
  • Fletcher Allen Health Care - University Health Center Campus
    Burlington, Vermont 05401, United States
  • MBCCOP - Massey Cancer Center
    Richmond, Virginia 23298-0037, United States

Showing the first 100 of 105 sites.

07

References and documents

Publications

  • Ganz PA, Green SJ, Hutchins L, et al.: Late cardiac effects of adjuvant CMF vs CAF in women with node negative breast cancer treated on SWOG 8897: initial results from SWOG 9342. [Abstract] Breast Cancer Res Treat 76 (Suppl 1): A-10, 2002.
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002900
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Feb 1997
Primary completion
Mar 2008
Last update
Oct 19, 2015

Study contacts

Patricia A. Ganz, MD
study chair · Jonsson Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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