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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00002934
First received: November 1, 1999
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Procedure: long-term screening
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Local Excision Alone for Selected Patients With DCIS of the Breast

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Actuarial local recurrence rate [ Time Frame: Assessed at 5 years ] [ Designated as safety issue: No ]
    Rate of in situ or invasive local breast cancer recurrence


Enrollment: 711
Study Start Date: April 1997
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pathology Review, Observation and Follow-up
Pathology review, observation and follow-up
 Procedure: long-term screening

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002934

  Show 30 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Lorie L. Hughes, MD Winship Cancer Institute of Emory University
  More Information

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

Publications:
Hughes L, Wang M, Page D, et al.: Five year results of intergroup study E5194: local excision alone (without radiation treatment) for selected patients with ductal carcinoma in situ (DCIS). [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-29, S15, 2006.

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00002934     History of Changes
Other Study ID Numbers: CDR0000065370, U10CA021115, E-5194
Study First Received: November 1, 1999
Last Updated: November 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
breast cancer in situ
ductal breast carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on June 17, 2013