EA1151

In this trial, women will be randomized to screening with Breast Tomosynthesis(TM) or Digital Mammography (DM). The frequency and number of screening examinations will vary with their menopausal status and whether they have breast cancer risk factors. All premenopausal women will undergo annual screening. Postmenopausal women will undergo biennial screening unless they have any of a list of specific risk factors. For postmenopausal women under age 70 (including those that have undergone menopause due to hysterectomy plus oophorectomy), those risk factors are a family history of breast cancer or known deleterious breast cancer mutation, dense breasts or hormone therapy. For women over age 70, the risk factors are dense breasts and hormone therapy. In order to assure balance of the most important breast cancer risk factors into the two randomization arms, we will stratify the randomization assignments by assigned screening frequency, study subjects current use of breast cancer chemoprevention, and enrolling site. Women eligible for annual screening will have 5 mammograms at baseline (T0) and four annual follow-up screening examinations (T1, T2, T3, and T4). Women eligible for biennial screening will have 3 mammograms at baseline (T0) T2 and T4. Participant accrual is expected to be complete within 36 months after the study is funded, allowing 6 months for study activation after funding commences. All participants will be followed for at least 4.5 to 8 years after study entry. To compare the cumulative proportions of participants experiencing the primary endpoint in the two study arms. To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All