LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Illumina panel: Determination of germline mutations using a recent panel including 113 genes from the "Illumina" protocol

Study summary

This is a cross-sectional and retrospective study of a cohort of patients with invasive lobular breast cancer (LBC) or in situ lobular neoplasia (LIN3).

The main endpoint is the relative frequency of patients with a germline mutation using a recent panel including 113 genes from the "Illumina" protocol.

In case of identification of a novel pathogenetic germline mutations, a personalized follow-up will be offered to each patient (in case of genes at moderate-, low-penetrance), or prophylactic mastectomy (in case of genes at high-penetrance).

Breast screening in moderate-, low-penetrance mutated patients should be performed periodically using digital mammography, ultrasound and MRI, and will be routinely observed.

Patients will be scheduled for follow-up at six-month intervals for 5 years at our outpatient clinic, and yearly thereafter

Eligibility

Primary outcome measure(s)

• Relative frequency of patients with a germline mutation — 1 month
  Frequency of germline mutation status in patients with in situ (LIN3) or invasive LBC or bilateral LBC or LBC with or without family history for breast cancer

Trial sites (1)

More European Institute of Oncology trials in Italy

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