Name of the Clinical Study: Understanding How CDH1 Germline Mutations Affect Hereditary Lobular Breast Cancer NCT04206891
Eligible patients: Patients who are under 45 years old with either invasive lobular carcinoma (ILC) of any stage or lobular carcinoma in situ (LCIS); lobular patients of any age with a positive family history of breast cancer; or patients with bilateral lobular breast cancer.
Summary: The aim of this observational clinical study is to investigate the prevalence of the CDH1 Genetic mutation in these 3 groups of women with no family history of Hereditary Diffuse Gastric Cancer (HDGC). Both CDH1 and BRCA 1/2 germline genetic tests will be offered.
Why is this Clinical Study Important: To date, no clear-cut genetic indicators for increased risk have been identified in patients with lobular breast cancer. This project is the first study dedicated to investigating the prevalence of the CDH1 genetic mutation in lobular breast cancer only; potentially leading to new International guidelines for CDH1 genetic screening and the effective surveillance and early detection of lobular breast cancer.
Background: Loss of E-cadherin expression with a CDH-1 mutation is frequently detected in lobular breast cancer. CDH1 hereditary mutations also are associated with diffuse gastric cancer. (DGC). Recently, some authors described CDH1 hereditary mutations in women with lobular breast cancer with early onset, or bilateral, or invasive lobular breast cancer with no family history of Hereditary Diffuse Gastric Cancer. These results are opening a new scenario, suggesting that CDH1 could be a susceptibility gene for lobular breast cancer in women without a family history of diffuse gastric cancer.
Clinical Study location: European Institute of Oncology (IEO), Milan, Italy. (Patients must be enrolled at the IEO or eligible patients must receive clinical evaluation to enroll at the IEO.)
How to learn more about whether participating in this clinical study is right for you: THIS TRIAL HAS COMPLETED ENROLLMENT. Send inquiries to giovanni.corso@ieo.it
The Lobular Breast Cancer Alliance shares information about ongoing clinical for lobular breast cancer. LBCA does not sponsor or run the clinical trials, and the scientific validity and safety of the trials is the responsibility of the trial investigators. Learn more by contacting the clinical trial coordinators listed above directly.
Patients should always discuss their participation in any clinical trial directly with their doctor – these Questions to Ask your Doctor may help. Learn more about participating in clinical trials. Learn about other lobular breast cancer clinical trials and studies.
