Breast Cancer Clinical Trial

Genetic Testing for All Breast Cancer Patients (GET FACTS)

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

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

450

Study ID:

NCT04245176

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Tara King, MD
Contact
617-632-3891
[email protected]
Tara King, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

450

Study ID:

NCT04245176

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.