Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake

NCT02517593 | Completed Phase 1

• 2 other identifiers: 15-006204CCM-003
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Breast Cancer

Keywords

BCRAT; IBIS; PRS; breast cancer; Tyrer-Cuzick

Outcome Measures

Primary Outcomes (1)

• Patient self-reported intention to take a breast cancer preventing medication

  up to 6 months after initial consultation

Secondary Outcomes (4)

• Proportion of patients who are taking preventive medications at year 1

  1 year

• Proportion of patients who are taking preventive medications at year 2

  2 years

• Endocrine related quality of life scores at 1 year

  1 year

• Endocrine related quality of life scores at 2 years

  2 years

Study Arms (1)

PRS

OTHER

Providing polygenic risk score (PRS)

Genetic: Polygenic Risk Score

Interventions

Polygenic Risk Score GENETIC

A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 77 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (\<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (\>40%).

Also known as: PRS

PRS

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \> 35 years old and \< 75 years old
• 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%
• Able to participate in all aspects of the study
• Understand and signed the study informed consent

You may not qualify if:

• 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
• Women with known BRCA1 and BRCA2 mutations
• Women with known contra-indications to Tamoxifen, raloxifene or exemestane
• Unable to give informed consent
• Prior history of invasive breast cancer or ductal carcinoma in situ
• At risk due to prior radiation therapy to the chest

Sponsors & Collaborators

• Mayo Clinic: lead
• CancerCare Manitoba: collaborator

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandhya Pruthi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 7, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)