Program for monitoring women at high risk for breast cancer

Chicago Alternative Prevention Study for Diverse Populations of High Risk Women

This study is trying to see if regular MRI screenings can help women at high risk for breast cancer catch it early and improve their chances of staying healthy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 25 Years and up
• Sex: Female
• Sponsor: University of Chicago (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT03729115 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include women with known genetic mutations associated with breast cancer or those with a high lifetime risk based on specific criteria.

Not a fit: Patients without significant risk factors for breast cancer or those who do not meet the eligibility criteria may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could lead to earlier detection of breast cancer in high-risk women, potentially improving survival rates.

How similar studies have performed: Other studies focusing on intensive surveillance for high-risk populations have shown promise, indicating that this approach is supported by prior research.

Eligibility criteria

Inclusion Criteria:

\- Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.

OR

* With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR
* 5-years risk ≥ 6% for women 40-64 OR
* 5-years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk \>= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR
* Patients with history of chest wall radiation received before age 35. OR
* To promote health equity, women of African Ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women.
* 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 cancer are eligible if they have completed all active treatments and are cancer free for two years.

Exclusion Criteria

* Undergoing active cancer treatment at the time of enrollment.
* Current pregnancy or plans for pregnancy within two years of enrollment.
* 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.

Where this trial is running

Chicago, Illinois

• 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

Conditions Breast Cancer