Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

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

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: 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

Relevance to patient case: not relevant