Oncotype DX in BRCA-mutated Breast Cancer Patients: Our Experience. A Retrospective Observational Monocentric Study

NCT06484725 | Completed

• 1 other identifier: CET 175-2024
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the distribution of the Oncotype DX RS® genomic test in patients with ER-positive and HER2-negative breast cancer treated from January 2012 to December 2021, focusing on patients presenting germline mutations.

Conditions

Breast Cancer; Genetic Predisposition

Keywords

BRCA1; BRCA2; Genomic test

Outcome Measures

Primary Outcomes (1)

• Oncotype DX assay and RS® in participants.

  To evaluate the Oncotype DX RS® distribution in ER-positive early BC patients comparing patients with a deleterious germline mutation, patients with a VUS in BC-related genes and patients with no mutation.

  30 days after surgery.

Secondary Outcomes (2)

• Oncotype DX assay and RS® in participants by menopausal or nodal status.

  30 days after surgery

• Distant or local recurrence.

  Up to 10 years after surgery

Study Arms (3)

Wild type patients

Patients with no mutations or VUS in Breast Cancer-related genes candidated to surgery as primary treatment and eligible for Oncotype DX assay.

Genetic: Oncotype DX assay

VUS patients

Patients with VUS in Breast Cancer-related genes candidated to surgery as primary treatment and eligible for Oncotype DX assay.

Genetic: Oncotype DX assay

Mutated patients

Patients with mutation in Breast Cancer-related genes candidated to surgery as primary treatment and eligible for Oncotype DX assay.

Genetic: Oncotype DX assay

Interventions

Oncotype DX assay GENETIC

Oncotype DX assay (Genomic Health, Inc, Redwood City, Calif) is a 21 gene panel developed to predict the risk of tumor recurrence in patients with ER-positive and human epidermal growth factor 2 (HER2)- negative breast cancer (BC); nowadays, this test represents a standard of care to guide adjuvant chemotherapy decision recommended in several guidelines. According to Oncotype DX Recurrent Score (RS)® a high RS shows a worse prognosis and predicts chemotherapy benefit in patients with ER-positive HER2-negative BC.

Mutated patients; VUS patients; Wild type patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients who underwent surgery as primary treatment and eligible for Oncotype DX assay.

You may qualify if:

• Age at diagnosis at least 18 years
• Women who underwent breast surgery in OSR
• Patients with ER-positive, HER2-unamplified early-stage BC who underwent the Oncotype DX assay, according to the standard of care.

You may not qualify if:

• Male
• ER negative or HER2 amplified disease
• Patient s who did not undergo breast surgery in OSR
• Patient s who did not undergo the Oncotype Dx assay

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oreste Davide Gentilini

  Vita-Salute San Raffaele University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: January 1, 2012
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)