Genetic Testing for All Breast Cancer Patients (GET FACTS)
1 other identifier
interventional
400
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jan 2020
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2020
CompletedFirst Posted
Study publicly available on registry
January 28, 2020
CompletedStudy Start
First participant enrolled
January 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 4, 2026
April 1, 2026
5.8 years
January 17, 2020
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in patient's assessment of their personal contralateral breast cancer risk
A short survey, self-developed in conjunction with the Dana Farber Cancer Institute professional survey core, will be used to compare changes in patients' personal contralateral breast cancer (CBC) risk assessment after quantitative versus standard genetic counseling. The question reads: "By the time you turn 80 years old, what do you believe is the chance you will develop cancer in the other (unaffected) breast?" and answer options are in 10% increments (ie. 0-10%, 11-20%, 21-30%). Their individual assessment of their risk will be collected before and after genetic counseling and will be compared to CBCRisk (for those without gene mutations) or ASK2ME (for those with gene mutations).
1 month
Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
Patient's will be surveyed about their personal propensity to choose a bilateral mastectomy as the surgical treatment of a unilateral cancer before and after quantitative vs. standard counseling. This survey question was self-developed in conjunction with the Dana Farber Cancer Institute professional survey core. The question reads: "How likely or unlikely are you to choose surgery to remove both breasts (bilateral mastectomy) for your cancer in one breast (unilateral or one-sided breast cancer)?"s answer options include the following: "Very unlikely, Somewhat unlikely, Unsure (neither likely nor unlikely), Somewhat likely, Very likely).
1 month
Secondary Outcomes (4)
Genetic Testing Satisfaction
6 Months
Contralateral Prophylactic Mastectomy (CPM) Rate
6 Months
Level of anxiety among participants, as measured by the PROMIS anxiety scale
6 months
Number of participants with decisional regret (testing and surgery choices)
6 months
Study Arms (2)
Quantitative Genetic Counseling
EXPERIMENTALThe research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups: \-- Quantitative genetic counseling: Discussion is guided by tables and graphs.
STANDARD GENETIC COUNSELING
ACTIVE COMPARATORThe research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups: \-- Standard genetic counseling: Standard of care discussion
Interventions
Standard genetic counseling: Standard of care discussion
Quantitative genetic counseling: Discussion is guided by tables and graphs.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Myriad Genetics, Inc.collaborator
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
Weiss A, Braun D, Stopfer J, Zhao J, McGrath M, Bradshaw KR, Rosito MS, Davis D, Garber JE, King TA. Genetic Testing for All Breast Cancer Patients: The GET FACTS Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551553. doi: 10.1001/jamanetworkopen.2025.51553.
PMID: 41525075DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tara King, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 17, 2020
First Posted
January 28, 2020
Study Start
January 31, 2020
Primary Completion
December 1, 2025
Study Completion
January 1, 2026
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.