Suspended

Local Excision Alone for Selected Patients With DCIS of the Breast

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What is being tested

long-term screening

Procedure
Who is being recruted

Adenocarcinoma+12

+ Breast Diseases

+ Carcinoma

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

Screening Study

Phase 2
Interventional
Study Start: June 1997
See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: June 22, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: June 25, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ (DCIS) prognosis. Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS. Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation. Evaluate patterns of salvage of recurrence and rates of breast conservation. Evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post DCIS excision. OUTLINE: This is a registration study stratified by histologic grade (high vs low or intermediate) and adjuvant tamoxifen therapy (yes vs no). Patients receive standard clinical and mammographic follow-up for greater than 10 years. If recurrence occurs, treatment will be at the discretion of the investigators. Patients may receive adjuvant oral tamoxifen daily for 5 years after local excision. A follow up magnification view mammogram must be taken after the last local excision, and microcalcification must be negative. Patients are followed every 6 months for the first 10 years, and then annually thereafter. PROJECTED ACCRUAL: 1000 (500 per stratum) eligible and evaluable patients will be enrolled at an estimated accrual rate of 250 patients per year.

NCT00002934
Principal SponsorEastern Cooperative Oncology Group
Last updated: June 22, 2023
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

711 patients to be enrolled

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

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

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 DiseasesCarcinomaCarcinoma in SituNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, DuctalBreast Carcinoma In SituBreast NeoplasmsCarcinoma, Ductal, Breast

Criteria

DISEASE CHARACTERISTICS: Histologically proven low or intermediate grade ductal carcinoma in situ (DCIS) of the breast No greater than 2.5 cm in the greatest dimension OR Histologically proven high-grade DCIS of the breast No greater than 1 cm in greatest dimension Region of DCIS must be at least 2.5 mm in greatest dimension (mammographic estimate of size allowed where pathologic measurement is impossible) DCIS must be non-palpable; detected by a mammogram or found incidentally by a breast biopsy Pathologically confirmed negative margins of at least 3 mm Breast must be suitable for breast conserving therapy Proper tumor size versus breast size No carcinoma or suspicious mammogram findings in other breast sites No prior in situ or invasive breast cancer Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Greater than 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: Not specified Other: No other invasive malignancies within the past 10 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No known HIV infection No Paget's nipple disease PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Adjuvant tamoxifen allowed Radiotherapy: No prior radiotherapy to breast No adjuvant radiotherapy Surgery: Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Pathology review, observation and follow-up

Study Objectives

Primary Objectives

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 30 locations

Emory University Hospital - Atlanta

Atlanta, United StatesOpen Emory University Hospital - Atlanta in Google Maps

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, United States

CCOP - Evanston

Evanston, United States

CCOP - Illinois Oncology Research Association

Peoria, United States
Suspended30 Study Centers