Breast CancerNCT00002900
SWOG-9342 Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
An observational study of Breast Cancer and Cardiac Toxicity, run by SWOG Cancer Research Network at 105 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Cardiac Toxicity
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 105 sitesUnited States
- Study dates
- Feb 1997to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically proven invasive adenocarcinoma of the breast with negative axillary lymph nodes
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
Trial locations and contacts
105 sites in 1 country.
105 sites in 1 country
United States105 sites
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Harrington Cancer Center
Amarillo, Texas, 79106
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
Boston Medical Center
Boston, Massachusetts, 02118
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
CCOP - Columbus
Columbus, Ohio, 43206
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
CCOP - Dayton
Dayton, Ohio, 45429
CCOP - Central Illinois
Decatur, Illinois, 62526
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
CCOP - Duluth
Duluth, Minnesota, 55805
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
University of Texas Medical Branch
Galveston, Texas, 77555-0565
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
CCOP - Kansas City
Kansas City, Missouri, 64131
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
Loyola University Medical Center
Maywood, Illinois, 60153-5500
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center
Orange, California, 92868
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
Oregon Cancer Institute
Portland, Oregon, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
University of California Davis Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
St. Louis University Health Sciences Center
St Louis, Missouri, 63110
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
CCOP - Northwest
Tacoma, Washington, 98405-0986
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
David Grant Medical Center
Travis Air Force Base, California, 94535
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
About this study
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
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.
- Conditions
- Breast Cancer, Cardiac Toxicity
- Being tested
- management of therapy complications
- Keywords
- stage I breast cancer, stage II breast cancer, ductal breast carcinoma, cardiac toxicity
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 1997
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patricia A. Ganz, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002900
- Sponsor's protocol ID
- CDR0000065237
- Other IDs
- U10CA032102, SWOG-9342
- Status last verified
- Oct 2015
- First submitted
- 1 Nov 1999
- Last updated
- 19 Oct 2015
- Results posted
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002900
- Acronym / sponsor ID
- CDR0000065237
- Conditions
- Breast Cancer, Cardiac Toxicity
- Keywords
- stage I breast cancer, stage II breast cancer, ductal breast carcinoma, cardiac toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1997
- Primary completion
- Mar 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically proven invasive adenocarcinoma of the breast with negative axillary lymph nodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Results publicationGanz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A. Ganz, MD study chair
Jonsson Comprehensive Cancer Center
105 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cardiac Toxicity, run by SWOG Cancer Research Network at 105 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.