Clinical trial · Interventional
Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake
Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake: A Pilot Study to Determine if a Polygenic Risk Score Influences the Decision to Accept Breast Cancer Preventive Medications (Tamoxifen, Raloxifene, or Exemestane) Amongst Non-BRCA Women at Risk
- 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)
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polygenic Risk Score | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- PRS
- description
- Providing polygenic risk score (PRS)
- interventionNames
- Genetic: Polygenic Risk Score
Primary outcomes (1)
- measure
- Patient self-reported intention to take a breast cancer preventing medication
- timeFrame
- up to 6 months after initial consultation
Secondary outcomes (4)
- measure
- Proportion of patients who are taking preventive medications at year 1
- timeFrame
- 1 year
- measure
- Proportion of patients who are taking preventive medications at year 2
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women \> 35 years old and \< 75 years old 2. Women with either of the following: A. a NCI-BCRAT 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force (32); or B. Women with a IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥5% 3. Able to participate in all aspects of the study 4. Understand and signed the study informed consent Exclusion Criteria: 1. Women whose BCRAT falls below the threshold (\<3 % 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is \<5% for the 10 year risk 2. Women with known BRCA1 and BRCA2 mutations 3. Women with known contra-indications to Tamoxifen, raloxifene or exemestane 4. Unable to give informed consent 5. Prior history of invasive breast cancer or ductal carcinoma in situ 6. At risk due to prior radiation therapy to the chest
References
Publications (0)
Data not yet available