A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer (CAPS)

The University of Chicago

Status

Enrolling

Conditions

Breast Cancer

Treatments

Procedure: Magnetic Resonance Imaging (MRI)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03729115

IRB18-0970

Details and patient eligibility

About

This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.

Enrollment

400 estimated patients

Sex

Female

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.