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

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00002900

Purpose

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
Breast Cancer Cardiac Toxicity	Procedure: management of therapy complications

Study Type:	Observational
Study Design:	Time Perspective: Prospective
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Estimated Enrollment:	420
Study Start Date:	February 1997
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002900

Show 105 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Patricia A. Ganz, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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.

ClinicalTrials.gov Identifier:	NCT00002900 History of Changes
Other Study ID Numbers:	CDR0000065237, U10CA032102, SWOG-9342
Study First Received:	November 1, 1999
Last Updated:	July 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012