Surveillance Program for Women at High Risk for Breast Cancer
A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
Recruiting
N/AInterventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
25 and older
Sex
Female
Study type
Interventional
Purpose
Screening
Participants needed
400 (estimated)
Sponsor
University of Chicago · Other
Who this trial is looking for
This trial is looking for women who are at high risk for breast cancer to participate in a program for early detection. Participants will undergo regular imaging studies and follow-up procedures at specific sites.
Are You a Good Fit for This Trial?
You may be able to join if
I have a known genetic mutation related to breast cancer.
I have a lifetime risk of 30% or higher for breast cancer.
I am between 40 and 64 years old with a 5-year risk of 6% or more.
I am 65 years or older with a 5-year risk of 6% or more and specific breast density.
I had chest wall radiation before age 35.
I am a woman of African ancestry under 45 with a family history of breast or ovarian cancer.
I am at least 25 years old.
I am willing to travel for imaging studies and follow-up.
You may not be able to join if
I am currently undergoing active cancer treatment.
I am pregnant or planning to become pregnant within two years.
I have a pacemaker or another metallic object in my body that affects an MRI.
I had breast surgery in the last two weeks.
I have had a bilateral mastectomy.
I have a history of kidney disease or abnormal kidney function.
I have a dye allergy that cannot be managed with medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.