A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
- Interventional
- Recruiting
- NCT03729115
Contact Information
Chicago Alternative Prevention Study for Diverse Populations of High Risk Women
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
Gender
Female
Age Group
25 Years and up
Accepting Healthy Volunteers?
Accepts Healthy Volunteers
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.
- 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.