Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ

June 20, 2023 updated by: Eastern Cooperative Oncology Group

Local Excision Alone for Selected Patients With DCIS of the Breast

RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer.

PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

711

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pretoria, South Africa, 0001
        • Pretoria Academic Hospitals
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
    • Illinois
      • Evanston, Illinois, United States, 60201
        • CCOP - Evanston
      • Peoria, Illinois, United States, 61602
        • CCOP - Illinois Oncology Research Association
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • CCOP - Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania Cancer Center
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37212
        • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • CCOP - Green Bay
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Medical Research and Education Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pathology Review, Observation and Follow-up
Pathology review, observation and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actuarial local recurrence rate
Time Frame: Assessed at 5 years
Rate of in situ or invasive local breast cancer recurrence
Assessed at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Lorie L. Hughes, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 1997

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 15, 2003

First Posted (Estimated)

April 16, 2003

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CDR0000065370
  • U10CA021115 (U.S. NIH Grant/Contract)
  • E-5194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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