Program for monitoring women at high risk for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program aims to create a registry for women who are at high risk for breast cancer, focusing on early detection through intensive surveillance methods. Participants will undergo regular Magnetic Resonance Imaging (MRI) to monitor for signs of breast cancer. The study includes women with specific genetic mutations or high lifetime risk factors, ensuring a targeted approach to breast cancer prevention. The program also promotes health equity by including women of African ancestry with familial cancer history.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Known carrier of PV in BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 or STK11 gene. Women with PV in any other cancer susceptibility genes are eligible if they also have an estimated lifetime risk of 30% or higher based on the integrated risk score, as described below.

OR

* Results from a CLIA approved laboratory with estimated lifetime risk of 30% or higher, based on integrated risk score that includes polygenic risk score (PRS) e.g Myriad Model.

OR

* WISDOM study participant recommended to have MRI every 6 months. OR
* Patients with history of chest wall radiation received before age 35. AND
* Must be at least 25 years old.
* Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
* Be able to give informed consent.

  * Patients with prior history of breast or ovarian or any cancer associated with inherited pathogenic mutations in BRCA1/2, PALB2, CDH1, TP53, PTEN or STK11 related mutation are eligible if they meet the inclusion criteria, have completed all active treatments and are cancer free.
  * Willing to travel to the University of Chicago Medicine

Exclusion Criteria

* Undergoing active cancer treatment at the time of enrollment.
* Current pregnancy.
* Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
* Breast surgery within two weeks of study entry.
* Women with history of bilateral mastectomy are not eligible
* History of kidney disease or abnormal kidney function.
* History of dye allergy unless it can be mediated with antihistamines and/or steroids

  * Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.
  * Women who are pregnant can return to the study after pregnancy. Expected timeframe to return back to the study after pregnancy is within 6 months post-delivery.
  * Women can return to the study after being treated for early-stage breast cancer. Timing of return to the study will be per investigator's discretion.

Where it's running

• University of California, San Diego
  La Jolla, California, United States Recruiting
• University of California, Davis
  Sacramento, California, United States Recruiting
• University Of Chicago Medicine Comprehensive Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Olufunmilayo I Olopade, MD — University of Chicago
• Study coordinator: Cancer Clinical Intake Office
• Email: cancerclinicaltrials@bsd.uchicago.edu
• Phone: 1-855-702-8222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.