Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women

Summary: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known which type of mammography is more effective in detecting breast cancer.
  PURPOSE: Screening and diagnostic trial to compare the effectiveness of two types of mammography in detecting breast cancer in women.

Detailed description: OBJECTIVES:
  -  Compare the diagnostic performance of digital mammography vs screen-film mammography, as measured by the area under the Receiver Operating Characteristic (ROC) curve, sensitivity, specificity, and positive and negative predictive values, in the detection of breast cancer in women.
  -  Compare the diagnostic accuracy of the digital mammogram obtained using each of the individual manufacturer's digital units vs screen-film mammography through retrospective reader studies.
  -  Determine the effects of patient characteristics, including age, lesion type, pathologic diagnosis, menopausal and hormonal status, breast density, and family history, on diagnostic accuracy of digital mammography.
  -  Determine the effects of technical parameters, including display type, machine type, and detector spatial and contrast resolution, on diagnostic accuracy of digital mammography.
  -  Determine the effect of reduced false-positive mammograms that are expected with digital mammography on the health-related quality of life and personal anxiety of women undergoing this screening experience.
  -  Compare the diagnostic performance of digital mammography with the rate of cancer in a set of cases through a retrospective reader study.
  -  Compare the effect of softcopy vs printed film display on the diagnostic performance of digital mammography through a retrospective reader study.
  -  Compare the effect of breast density on the diagnostic accuracy of digital mammography vs screen-film mammography through a retrospective reader study.
  -  Compare the image quality and breast radiation dose in digital vs screen-film mammography in these participants.
  -  Determine the temporal variations in image quality, breast radiation dose, and other quality control parameters in the participating study centers.
  OUTLINE: This is a randomized, multicenter study. Participants with postitive screening results are stratified according to age (under 50 vs 50-59 vs 60-70 vs over 70). Participants are randomized to one of two treatment arms.
  -  Arm I: Participants undergo a two-view screen-film mammogram followed by a two-view digital mammogram of each breast.
  -  Arm II: Participants undergo a two-view digital mammogram followed by a two-view screen-film mammogram of each breast.
  Quality of life is assessed before the screening mammogram in the first 800 women enrolled. In an additional 1,200 participants (600 with positive screening results and 600 with negative screening results), quality of life is assessed shortly after the screening mammogram and at 1 year.
  Participants are followed at 1 year with a repeat screen-film or digital mammogram.
  PROJECTED ACCRUAL: A total of 49,500 participants (24,750 per arm) will be accrued for this study within 18 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Asymptomatic women presenting for screening mammography
  -  No focal dominant lump or bloody or clear nipple discharge
  -  No prior breast cancer treated with lumpectomy
  -  Prior mastectomy for breast cancer allowed
  -  No breast implants
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Sex:
  -  Female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant