Completed

A STUDY OF THE LATE CARDIAC EFFECTS OF TWO DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENTS IN WOMEN WITH NODE NEGATIVE BREAST CANCER TREATED ON SWOG-8897

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What is being collected

Procedure Data

Collected from today forward - Prospective
Procedure
Who is being recruted

Adenocarcinoma+19

+ Breast Diseases

+ Carcinoma

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: February 1997
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: October 19, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002900
Principal SponsorSWOG Cancer Research Network
Last updated: October 19, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaBreast DiseasesCarcinomaCardiovascular DiseasesHeart DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPathologic ProcessesRadiation InjuriesSkin DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesSkin and Connective Tissue DiseasesNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, DuctalChemically-Induced DisordersDrug-Related Side Effects and Adverse ReactionsBreast NeoplasmsCarcinoma, Ductal, BreastCardiotoxicity

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 105 locations

MBCCOP - Gulf Coast

Mobile, United StatesOpen MBCCOP - Gulf Coast in Google Maps

CCOP - Western Regional, Arizona

Phoenix, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

Phoenix, United States

Veterans Affairs Medical Center - Tucson

Tucson, United States
Completed105 Study Centers