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

Study Overview
=================
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.

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

Conditions
-----------------
BRCA-Associated Breast Carcinoma

Intervention / Treatment
-----------------
* Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with germline BRCA1/2 patitents<br>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).<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast somatic mutations | 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. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian somatic mutations | 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. | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BRCA1/2, Breast cancer, Ovarian cancer, Platinum salts, PARP inhibitors