Clinical trial · Interventional
Genetic Testing for All Breast Cancer Patients (GET FACTS)
NCT04245176CI-TRIAL-00110275completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Genetic Testing | — | UNRESOLVED | — |
| in Situ Breast Cancer | — | UNRESOLVED | — |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quantitative Genetic Counseling | Behavioral | — | UNRESOLVED |
| Standard Genetic Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Quantitative Genetic Counseling
- 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: \-- Quantitative genetic counseling: Discussion is guided by tables and graphs.
- interventionNames
- Behavioral: Quantitative Genetic Counseling
- type
- ACTIVE_COMPARATOR
- label
- STANDARD GENETIC COUNSELING
- 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
- interventionNames
- Behavioral: Standard Genetic Counseling
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWeiss 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 41525075