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Protocol No. EA1151

Principal Investigator Elezaby, Mai

Phase N/A

Age Group Adult

Scope National

Sponsor Type National

Title Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Objective
This study is being done to answer the following question:
  • Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast?
  • We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers

  • Treatment
    Arm A: Digital Mammography (DM):
  • Annual DM Screening (Baseline, 12-, 24-, 36-, 48- Months, or Until Cancer Detected)
  • Biennial DM Screening (Baseline, 24-, 48- Months or Until Cancer Detected)
    Arm B: Tomosynthesis (TM)
  • Annual TM Screening (Baseline 12-, 24-, 36-, 48- Months, or Until Cancer Detected)
  • Biennial TM Screening (Baseline, 24-, 48- Months or Until Cancer Detected)

  • Description Tomosynthesis Mammographic Imaging Screening Trial

    Key Eligibility
  • Women age 45 or older and under age 75 at the time of study entry
  • Women of childbearing potential must not be known to be pregnant or lactating
  • Must be scheduled for, or have intent to schedule, a screening mammogram
  • Must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol
  • Must be willing and able to provide a written informed consent
  • Must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) Patients with breast pain are eligible as long as other criteria defined by the protocol
  • Must not have had a screening mammogram within the last 11 months prior to date of randomization
  • Must not have previous personal history of breast cancer including ductal carcinoma in situ
  • Must not currently have breast enhancements (e.g., implants or injections)
    To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above: Patients are pre-menopausal; OR Post-menopausal aged 45-69 with any of the following three risks factors:
  • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), OR
  • Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, OR
  • Currently on hormone therapy; OR
  • Post-menopausal ages 70-74 with either of the following two risk factors:
  • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), OR
  • Currently on hormone therapy
    Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry. For the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal
  • Women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
  • All other postmenopausal women are eligible for inclusion in the biennial screening regimen
    For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND have not had a prior mammogram, breast density will be determined by the radiologist’s recording of it at the time of interpretation of the first study screening examination, either DM or TM. For those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic 2D portion of the TM examination. Such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the TMIST population
  • Breast density will be determined by prior mammography reports, when available. All other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park