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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is building a registry, or list of health records, for women at high risk for breast cancer. It follows women who get frequent screening tests to find breast cancer early.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 25 and meet at least one of the next four risk criteria.
  • You have a harmful change in BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1, or STK11. For other cancer-risk genes, you also need a combined score showing a lifetime breast cancer risk of at least 30%.
  • A CLIA-approved lab reports a lifetime breast cancer risk of at least 30%, using a combined score that includes risk from many genes.
  • You are in the WISDOM study and were advised to get an MRI scan every 6 months.
  • You had radiation treatment to your chest before age 35.
  • You can give informed consent, meaning you understand and agree to join. You are willing to travel to a study site, including University of Chicago Medicine, for scans and needed follow-up care.
  • If you had breast, ovarian, or another cancer linked to the listed inherited gene changes, you must meet the other rules, have finished active treatment, and be cancer-free.
  • You may use hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, or PARP inhibitors as added treatment. You may also be in a cancer-prevention drug study.

Who can't join

  • You are getting active cancer treatment when you join.
  • You are pregnant. You may return after pregnancy, with return expected within 6 months after giving birth.
  • You have a pacemaker or metal in your body that interferes with MRI scans.
  • You had breast surgery within 2 weeks before joining.
  • You had both breasts removed.
  • You have a history of kidney disease or abnormal kidney function.
  • You have an allergy to scan dye that cannot be managed with allergy medicines or steroids.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

CA

IL