Summary

Eligibility
for females ages 25 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Sacramento, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

Chicago Alternative Prevention Study for BreAst CAncer inHigh Risk Women - CAPSBRACA

Keywords

Breast Cancer, Breast Neoplasms, Magnetic Resonance Spectroscopy, Magnetic Resonance Imaging (MRI)

Eligibility

You can join if…

Open to females ages 25 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California, Davis accepting new patients
    Sacramento California 95817 United States
  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • University Of Chicago Medicine Comprehensive Cancer Center accepting new patients
    Chicago Illinois 60637 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Chicago
ID
NCT03729115
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated