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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05763472

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
BRCA-Associated Breast Carcinoma	Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Molecular Landscape Involved in the Onset of Breast Cancer in Patients With Germline BRCA-1/2 Mutations, During or After Therapy With Platinum-based Agents and/or PARP-inhibitors for Ovarian Cancer

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with germline BRCA1/2 patitents 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.	Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500). Next-generation sequencing (NGS) analysis with TruSight Oncology 500 (TSO 500) is performed on tumor samples from breast and ovarian cancer of the enrolled patients.

Arm

Intervention/Treatment

Patients with germline BRCA1/2 patitents

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.

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

Next-generation sequencing (NGS) analysis with TruSight Oncology 500 (TSO 500) is performed on tumor samples from breast and ovarian cancer of the enrolled patients.

Outcome Measures

Primary Outcome Measures

Breast somatic mutations [15 months]
To describe the presence of somatic mutations on breast tumor tissue, in patients with breast cancer arising during or after treatment with platinum-based chemotherapy or PARP-inhibitors for ovarian cancer.

Secondary Outcome Measures

Ovarian somatic mutations [15 months]
To describe the presence of somatic mutations on ovarian tumor tissue, in patients with breast cancer arising during or after treatment with platinum-based chemotherapy or PARP-inhibitors for ovarian cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.