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

Breast Cancer Clinical Trial

Official title:

Local Excision Alone for Selected Patients With DCIS of the Breast

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00002934
• Other study ID #: CDR0000065370
• Secondary ID: U10CA021115E-519
• Status: Terminated
• Phase: Phase 2
• Start date: June 25, 1997
• Est. completion date: October 2012

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 711
• Est. completion date: October 2012
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• long-term screening

Locations

Country	Name	City	State
South Africa	Pretoria Academic Hospitals	Pretoria
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Green Bay	Green Bay	Wisconsin
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus	Nashville	Tennessee
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	CCOP - Wichita	Wichita	Kansas
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (2)

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

Hughes LL, Wang M, Page DL, Gray R, Solin LJ, Davidson NE, Lowen MA, Ingle JN, Recht A, Wood WC. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Nov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actuarial local recurrence rate	Rate of in situ or invasive local breast cancer recurrence	Assessed at 5 years