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

Eastern Cooperative Oncology Group

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: long-term screening

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00002934

E-5194

CDR0000065370

U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 711 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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711 participants in 1 patient group

Pathology Review, Observation and Follow-up

No Intervention group

Description:

Pathology review, observation and follow-up

Treatment:

Procedure: long-term screening