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

Recruiting

• Conditions: BRCA-Associated Breast Carcinoma
• Interventions: Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).

• Registration Number: NCT05763472
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-10
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with germline BRCA1/2 patitents	Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, RM, Italy