NCT05763472

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

February 28, 2023

Last Update Submit

March 9, 2023

Conditions

BRCA-Associated Breast Carcinoma

Keywords

BRCA1/2Breast cancerOvarian cancerPlatinum saltsPARP inhibitors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ovarian somatic mutations

    15 months

Study Arms (1)

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).

Interventions

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

Patients with germline BRCA1/2 patitents

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Other malignancies in the last 2 years.
  • Prior chemotherapy or radiation therapy for other malignancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsOvarian Neoplasms

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Central Study Contacts

IDA PARIS, MD

CONTACT

+39 0630156493ida.paris@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

March 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)