Breast CancerNCT04245176
Genetic Testing for All Breast Cancer Patients (GET FACTS)
A study testing Standard Genetic Counseling and Quantitative Genetic Counseling in people with Breast Cancer and Invasive Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer
- What is being tested?
- Standard Genetic Counseling and Quantitative Genetic Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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
Read the detailed description
- The 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
- Quantitative genetic counseling: Discussion is guided by tables and graphs.
- Participants will be on the research study for up to six months, with an optional extension to two years.
- It is expected that about 450 people will participate.
- This research study is a Feasibility Study, which is the first-time investigators are examining this form of genetic counseling.
- This is a randomized study. Randomization means being put into a group by chance. It is like flipping a coin. Neither the participant nor the Investigator will choose the group the participant is assigned to.
- Being tested
- Standard Genetic Counseling, Quantitative Genetic Counseling
- Keywords
- Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Genetic Testing, Quantitative genetic counseling, Standard genetic counseling
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Genetic CounselingBehavioural
Standard genetic counseling: Standard of care discussion
Quantitative Genetic CounselingBehavioural
Quantitative genetic counseling: Discussion is guided by tables and graphs.
| Study group | Role | What they receive |
|---|---|---|
| Quantitative Genetic Counseling | Experimental | The 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. Receives: Behavioral: Quantitative Genetic Counseling |
| STANDARD GENETIC COUNSELING | Active comparator | The 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 Receives: Behavioral: Standard Genetic Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 1 month
Secondary outcomes (4)
Genetic Testing Satisfaction
Breast cancer patient satisfaction with genetic counseling practices,comparing the delivery of results by quantitative counseling versus standard counseling, as measured by the Genetic Testing Satisfaction Survey (GTS).
Measured: 6 Months
Contralateral Prophylactic Mastectomy (CPM) Rate
CPM rates will be measured and compared between patients who undergo quantitative versus standard genetic counseling.
Measured: 6 Months
Level of anxiety among participants, as measured by the PROMIS anxiety scale
Patients' level of anxiety will be compared between quantitative versus standard genetic counseling to monitor that we are avoiding undue stress on the patients. We will use the Patient-Reported Outcomes Information System (PROMIS) anxiety scale. Scores can range from 8-40, with 40 indicating worse anxiety.
Measured: 6 months
Number of participants with decisional regret (testing and surgery choices)
Decisional regret will be measured and compared between quantitative versus standard genetic counseling, for both the decision to undergo genetic testing and the surgical choice that was made.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start31 Jan 2020
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Myriad Genetics, Inc.
- Responsible party
- Principal investigator, Laura S. Dominici, MD, Brigham and Women's Hospital
- Investigators
- Tara King, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245176
- Sponsor's protocol ID
- 19-509
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41525075
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Testing for All Breast Cancer Patients (GET FACTS)
- ClinicalTrials.gov ID
- NCT04245176
- Acronym / sponsor ID
- 19-509
- Keywords
- Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Genetic Testing, Quantitative genetic counseling, Standard genetic counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Myriad Genetics, Inc.
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- The 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
- Quantitative genetic counseling: Discussion is guided by tables and graphs.
- Participants will be on the research study for up to six months, with an optional extension to two years.
- It is expected that about 450 people will participate.
- This research study is a Feasibility Study, which is the first-time investigators are examining this form of genetic counseling.
- This is a randomized study. Randomization means being put into a group by chance. It is like flipping a coin. Neither the participant nor the Investigator will choose the group the participant is assigned to.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quantitative Genetic Counseling | Experimental | Behavioral: Quantitative Genetic CounselingThe 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 comparator | Behavioral: Standard Genetic CounselingThe 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Genetic CounselingStandard genetic counseling: Standard of care discussion | Behavioural | STANDARD GENETIC COUNSELING |
| Quantitative Genetic CounselingQuantitative genetic counseling: Discussion is guided by tables and graphs. | Behavioural | Quantitative Genetic Counseling |
Primary outcome
Change in patient's assessment of their personal contralateral breast cancer risk
Time frame: 1 month
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).
Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
Time frame: 1 month
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).
4 secondary outcomes
Genetic Testing Satisfaction
Time frame: 6 Months
Contralateral Prophylactic Mastectomy (CPM) Rate
Time frame: 6 Months
Level of anxiety among participants, as measured by the PROMIS anxiety scale
Time frame: 6 months
Number of participants with decisional regret (testing and surgery choices)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41525075Weiss 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara King, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Genetic Counseling and Quantitative Genetic Counseling in people with Breast Cancer and Invasive Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient's assessment of their personal contralateral breast cancer risk (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.