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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05763472

Acronym

Gen-eva

Enrollment

Registered

2023-03-10

Start date

2022-03-01

Completion date

2023-06-01

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRCA-Associated Breast Carcinoma

Keywords

BRCA1/2, Breast cancer, Ovarian cancer, Platinum salts, PARP inhibitors

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.

Interventions

GENETICNext-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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactIDA PARIS, MD

ida.paris@policlinicogemelli.it+39 0630156493

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026