Recruiting

Tamoxifen

Sponsor:

Columbia University

Code:

NCT07899151

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

RealRisks Decision Aid

Study Details

Brief summary:

The purpose of this study is to find out whether electronic tools that provide information and reminders to people at high risk for breast cancer and their healthcare providers can increase the use of medications, such as tamoxifen, that may help lower the risk of developing breast cancer. The study will also look at how these tools can be successfully used as part of routine medical care.

Conditions

Breast Cancer

Study ID

NCT07899151

Start date

Oct 7, 2026

Status verified date

Nov, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Women, age 40-79 years (ages which overlap for the BCSC and ASCVD risk calculators)
2. High-risk for breast cancer based upon any of the following criteria:

  • Histologically-confirmed atypical hyperplasia or lobular carcinoma in situ
  • At least a 3% breast cancer risk at 5 years or 5% risk at 10 years or 20% lifetime risk according to one of the following breast cancer risk models: Breast Cancer Surveillance Consortium risk calculator V3 (https://tools.bcsc-scc.ucdavis.edu/BC5yearRisk/#calculator), Gail Breast Cancer Risk Assessment Tool (https://bcrisktool.cancer.gov/calculator.html), Tyrer-Cuzick model V8 (https://ibis-risk-calculator.magview.com), or BOADICEA canrisk model (https://www.canrisk.org)
  • Known carriers of germline pathogenic/likely pathogenic variant in the following breast cancer predisposition genes (ATM, BRCA2, CHEK2, or PALB2)
  • Prior chest wall irradiation before age 30 years
3. English- or Spanish-speaking
4. Has a clinician affiliated with NYP/CUIMC
5. Able to provide written, verbal or online informed consent

Exclusion Criteria:

  • Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control

Standard educational materials regarding breast cancer chemoprevention.

experimental: Intervention

Standard educational materials plus access to the RealRisks web-based decision aid. RealRisks provides personalized breast cancer and ASCVD risk assessment, educational modules, and individualized action planning.

Interventions

RealRisks Decision Aid

Behavioral/Educational Material

Primary outcome measure

  • Chemoprevention Uptake [ Time Frame: 12 months after randomization ]

Central Contacts and Locations

Central contacts

Research Nurse Navigator

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Rita Kukafka, DrPH, MA

212-305-1945rk326@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Research Nurse Navigator

cancerclinicaltrials@cumc.columbia.edu

212-342-5162

More Information

Sponsor

Columbia University

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Columbia University on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.