Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation (Gen-eva)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: BRCA-Associated Breast Carcinoma

Treatments: Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).

Study type: Observational

Funder types: Other

Identifiers

NCT05763472

4817

Details and patient eligibility

About

This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent.
• Age older than 18 years.
• Germline BRCA1/2 mutation.
• Histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or PARP inhibitors.
• Histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer.
• Availability of FFPE breast and ovarian tumor samples.

Exclusion criteria

• Other malignancies in the last 2 years.
• Prior chemotherapy or radiation therapy for other malignancies.

Trial design

10 participants in 1 patient group

Patients with germline BRCA1/2 patitents

Description:

Women with germline BRCA-1/2 mutations, previously treated or undergoing treatment with platinum-based chemotherapy and/or PARP inhibitors for ovarian cancer, who have developed breast cancer, subjected to genomic profiling of breast and ovarian tumor samples.

Treatment:

Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).