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

NCT ID: NCT05763472

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-06-01

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.

Conditions

BRCA-Associated Breast Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

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

Intervention Type: GENETIC

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.

Interventions

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.

Intervention Type: GENETIC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

IDA PARIS, MD

Role: CONTACT

ida.paris@policlinicogemelli.it

+39 0630156493

Facility Contacts

IDA PARIS, MD

Role: primary

ida.paris@policlinicogemelli.it

+39 0630156493

Other Identifiers

4817

Identifier Type: -

Identifier Source: org_study_id