Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Cancer Categories

Breast

Karmanos Trial ID

EA1151

NCT ID

NCT03233191

Age Group

Adult

Scope

National

Phase

Phase II

Principal Investigator

Agnieszka
Choromanska, M.D.
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Objective:

Primary Objective:

To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an "advanced" breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). For purposes of this study, "advanced" cancers are those meeting any of the following criteria at any time during a period of 4.5 years from randomization:

there are distant metastases,
there are positive lymph nodes*,
the cancer is invasive and is greater than or equal to 20 mm in size, or
the cancer is invasive and is greater than 10 mm and less than 20 mm in size and is either: 1) ER- and PR- and HER2-, or is 2) HER2+.

*lymph nodes with micrometastases (none greater than 2 mm) and/or isolated tumor cells are not considered lymph node positive for definition of advanced cancer. All cancers that meet these criteria that present within 4.5 years of randomization will be counted in the primary endpoint.

Secondary Objectives:

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.

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Eligibility

Inclusion Criteria:

Women of childbearing potential must not be known to be pregnant or lactating
Patients must be scheduled for, or have intent to schedule, a screening mammogram
Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent
Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not have breast enhancements (e.g., implants or injections)
ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
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 DM 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 Tomosynthesis Mammographic Imaging Screening Trial (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

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

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