TOMOSYNTHESIS MAMMOGRAPHIC IMAGING SCRENING TRIAL (TMIST)

Not Applicable

Conditions: -Z123 Special screening examination for neoplasm of breast
Special screening examination for neoplasm of breast
Z123

Registration Number: PER-102-20

Lead Sponsor: ECOG ACRIN Cancer Research Group,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients must be women age 45 or older and under age 75 at the time of study entry 2. Patients must be scheduled for, or have intent to schedule, a screening mammogram. 3. Patients must not have new symptoms or signs of benign or malignant breast disease (eg, bloody or clear nipple discharge, breast lump) based on physician physical exam or self breast exam that have not been previously worked up with imaging. Patients with physiologic nipple discharge or breast pain are eligible as long as other criteria in 3.1.6 are met.

Exclusion Criteria

1. Pregnancy or breastfeeding 2. Signs or symptoms of breast disease: tumor, discharge, etc. (Mastalgia is not a reason for exclusion.) 3. Previous history of breast cancer, including in situ.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Diagnosis by medical examination, images and / or pathology report of the following: (a) distant metastases, (b) positive lymph nodes, (c) invasive carcinoma with a size greater or equal than 20 mm, or (d) invasive carcinoma greater than 10mm and less than 20mm in size and is: / ER- and PR- and HER2-, or is // HER2 +<br>Measure:To compare the proportion of the participants in the arms of the study of tomosynthesis (3D mammography) and digital mammography (2D) who experienced the appearance of an advanced breast cancer.<br>Timepoints:A period of 4.5 years from randomisation, including the period of active detection and clinical follow-up after the last evaluation<br>

Secondary Outcome Measures