Study 6 of 39894 for search of: United States
Previous Study Return to Search Results Next Study

Full Text View
Tabular View
No Study Results Posted
Related Studies
Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
This study has been completed.
Study NCT00002900   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

November 1, 1999
February 6, 2009
February 1997
 
 
Complete list of historical versions of study NCT00002900 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
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.

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.

 
Observational
 
  • Breast Cancer
  • Cancer-Related Problem/Condition
Procedure: management of therapy complications
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
420
 
March 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
 
United States
 
 
NCT00002900
 
SWOG-9342
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Patricia A. Ganz, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2004

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.