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Protocol Summary


Protocol No.
PSCI-19-080
Prinicipal Investigator
Sivarajah, Rebecca
Phase
N/A
Age Group
Adult
Scope
National
Secondary Protocol No.
EA1151
Title
Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
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:
(a) there are distant metastases,
(b) there are positive lymph nodes*,
(c) the cancer is invasive and is greater than or equal to 20 mm in size, or
(d) the cancer is invasive and is greater than 10 mm and less than 20 mm in size and is either:
i ER- and PR- and HER2-, or is
ii 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.

Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center