CompletedNot Applicable

Genetic Testing for All Breast Cancer Patients (GET FACTS)

United States400 participantsStarted 2020-01-31

Plain-language summary

This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer This research study involves an expedited and surgery-specific form of genetic counseling. The names of the study methods involved in this trial are/is: * Quantitative genetic counseling (discussion is guided by tables and graphs) * Standard genetic counseling

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Patients with a new breast cancer diagnosis (invasive or in-situ) considering genetic testing * Patients with good understanding of written and spoken English * Patients with apparent cognitive capacity to make surgical decisions for themselves * Patients who are medically cleared for surgery * Patients must be at least age 18 but under 79 Exclusion Criteria * Previous breast cancer diagnosis (invasive or DCIS) * Metastatic breast cancer * Patients who have received prior broad-based panel testing (prior BRCA1/2 testing with negative results allowed) * Bilateral breast cancer * Known medical or surgical contraindication to contralateral mastectomy * Hematologic malignancy necessitating skin biopsy/fibroblast culture for germline genetic testing malignancy other than cervical cis or basal or squamous cell skin cancers.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in patient's assessment of their personal contralateral breast cancer risk

Timeframe: 1 month

Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question

Timeframe: 1 month

Trial details

NCT IDNCT04245176

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Breast Cancer trials