Clinical trial NCT00002934: Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
Official title: Local Excision Alone for Selected Patients With DCIS of the Breast
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer in situ
ductal breast carcinoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-16
Enrollment: 711
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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 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

Primary outcomes:
measure: Actuarial local recurrence rate
timeFrame: Assessed at 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Decatur
country: United States
facility: Veterans Affairs Medical Center - Atlanta (Decatur)
state: Georgia
city: Evanston
country: United States
facility: CCOP - Evanston
state: Illinois
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Veterans Affairs Medical Center - Indianapolis (Roudebush)
state: Indiana
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: New England Medical Center Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Hackensack
country: United States
facility: CCOP - Northern New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Tulsa
country: United States
facility: CCOP - Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Green Bay
country: United States
facility: CCOP - Green Bay
state: Wisconsin
city: Marshfield
country: United States
facility: CCOP - Marshfield Medical Research and Education Foundation
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospitals
Study officials:
affiliation: Emory University
name: Lorie L. Hughes, MD
role: STUDY_CHAIR
References:
citation: 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 10;27(32):5319-24. doi: 10.1200/JCO.2009.21.8560. Epub 2009 Oct 13.
citation: 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.
citation: Solin LJ, Gray R, Hughes LL, Wood WC, Lowen MA, Badve SS, Baehner FL, Ingle JN, Perez EA, Recht A, Sparano JA, Davidson NE. Surgical Excision Without Radiation for Ductal Carcinoma in Situ of the Breast: 12-Year Results From the ECOG-ACRIN E5194 Study. J Clin Oncol. 2015 Nov 20;33(33):3938-44. doi: 10.1200/JCO.2015.60.8588. Epub 2015 Sep 14.