Personalized Breast Cancer Screening

Summary

The purpose of the study is to measure short-term safety and efficacy of personalized vs. standard mammography screening among 50-67-year aged women. The CE-marked risk model incorporates genetic data, family history, lifestyle/hormonal factors and mammographic density.

Consenting women will be 1:1 randomized to a control group receiving no risk measurement and continuing their normal biennial mammography, while women in the intervention group will receive risk measurement and an ensuing risk stratified screening programme.

Questionnaire information on life quality, breast cancer worry and anxiety will be collected at baseline and different timepoints later from both groups. The primary endpoint - the fraction of low risk women rejecting the recommended extension of screening interval from 2 to 4 years, will be measured 2 years and 4 years after inclusion. PRSONAL will be a success if this fraction is lower than 30%. Secondary outcomes, include quality of life, breast cancer worry and anxiety.

Commitment from the target group is key for success, and interview studies followed by a questionnaire survey among women will feed into construction of a citizen directed web-based Risk Communication Tool. This tool will collect risk information, present the risk estimate and provide individual risk communication, while monitoring involvement, acceptance, and psychosocial consequences of personalized screening. The large volume of individuals undergoing screening, necessitates automated, but individualized interaction with the screened individuals. The tool will constitute such a platform.

In total, 2200 women will be randomized 1:1 without blinding to a control group assigned to the standard screening program, and an intervention group, which will be offered a risk measurement and risk stratified screening accordingly. Women in the intervention group are stratified into four risk groups. Depending on the risk group the women will be offered a mammography every 1-4 years. The control group are assigned to the standard national screening program with biennial screening.

The primary outcome of the study will be the proportion of women in the low risk group, who choose to have the next mammography within two years from the enrollment, indicating that the women will have rejected the proposed de-escalated screening intensity. Moreover, potential harms such as increased anxiety, worry or reduced quality of life will be measured via self-report questionnaires.

Conditions

• Breast Cancer

Interventions

OTHER

Risk stratified arm

* Complete a questionnaire about family history of breast cancer, lifestyle, reproductive history (baseline) * Measurement of height and weight (baseline) * Complete a mammography (baseline and every 1-4 years according to the risk-group) * Complete questionnaires about quality of life, breast cancer worry and anxiety (safety measures) (baseline, day 180, 365, and 800) * Provide a blood sample for analysis of 313 common genetic variants associated with risk of breast cancer (baseline) * Receive a screening schedule recommendation.

OTHER

Control arm

* Complete a questionnaire about family history of breast cancer, lifestyle, reproductive history (baseline) * Measurement of height and weight (baseline) * Complete a mammography (baseline and every second year) * Complete questionnaires about quality of life, breast cancer worry and anxiety (safety measures) (baseline, day 180, 365, and 800)

Sponsors & Collaborators

• Danish Cancer Society

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• The Novo Nordic Foundation

  collaborator OTHER

• Herlev and Gentofte Hospital

  lead OTHER

Principal Investigators

• Stig E Bojesen, MD, Professor · Dept. Clinical Biochemistry, Herlev Gentofte Hospital, Copenhagen University Hospital, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

67 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-02

Primary Completion

2027-02-01

Completion

2034-12-31

Countries

• Denmark

Study Locations