Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484725
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Oncotype DX in BRCA-mutated Breast Cancer Patients Our Experience A Retrospective Observational Monocentric Study
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Oncotype DX in BRCA-mutated Breast Cancer Patients Our Experience A Retrospective Observational Monocentric Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OnBRA
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
Detailed Description:
In the past decades genetic testing for cancer susceptibility has become essential in breast cancer BC management Up to 10 of BC cases are associated with an inherited mutation in various genes especially BRCA 1 and BRCA 2 Estrogen receptor ER positivity is observed in 22 on BRCA 1 and 77 of BRCA 2 mutation carrier moreover other genes are strongly related to ER-positive cancer
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 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
Combining Oncotype DX RS with other risk factor elements in particular germline mutations could help to select patients who would benefit from an appropriate adjuvant therapy
This retrospective observational study aims to evaluate Oncotype DX RS distribution in ER-positive HER2-negative BC patients treated from January 2012 to December 2021 focusing on patients harboring mutation in BC-associated genes compared to the general population
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 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
Combining Oncotype DX RS with other risk factor elements in particular germline mutations could help to select patients who would benefit from an appropriate adjuvant therapy
This retrospective observational study aims to evaluate Oncotype DX RS distribution in ER-positive HER2-negative BC patients treated from January 2012 to December 2021 focusing on patients harboring mutation in BC-associated genes compared to the general population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None