Clinical Trials

JBCRG-C12(PROGRESS)
NEW

Treatment patterns and prognosis based on recurrence score in breast cancer patients who participated in the "Oncotype DX Breast Recurrence Score Testing Results Provision Program"

Status
Now Recruiting

Objectives
To examine the treatment patterns and prognosis using Oncotype DX and verify the correlation between the prevention effect of cancer recurrence of S-1 and the Oncotype DX🄬 recurrence score in ER-positive and HER2-negative early breast cancer patients who underwent the "Oncotype DX Breast Recurrence Score Testing Results Provision Program"

Subjects
Patients diagnosed with breast cancer at each institution who underwent the "Oncotype DX Breast Recurrence Score Testing Results Provision Program” between January 2022 and July 2023

Endpoints
Primary endpoint
Invasive disease free survival(iDFS)

Secondary endpoint
・Overall survival(OS)
・Disease free survival(DFS)
・Distant disease free survival: (DDFS)
・Distribution of recurrence
scores and treatment selections based on clinicopathological
factors for the entire population tested with Oncotype DX
・Treatment patterns and
prognosis, including
chemotherapy administration
rates by recurrence score
・Correlation between Oncotype DX Recurrence Score and OS,
DFS, and DDFS after S-1
administration
・Correlation between Oncotype DX Recurrence Score and OS, DFS, and DDFS after
Abemaciclib administration
・Treatment completion rate and reasons for discontinuation

Trial Period
From the Date of Research permission
To December 31, 2029

Lead Principal Investigator
Kei Koizumi, MD, PhD.
Department of Breast Surgery, Hamamatsu University School of Medicine

Target Sample Size
N=5,000

Regimen
The study is a multi-institutional retrospective observational study.
Participating institutions will collect data of all patients from existing information such as electronic medical records, who have undergone the ”Oncotype DX Breast Recurrence Score Testing Results Provision Program” between January 2022 and July 2023.

Source of Funding
Exact Sciences

Conference Presentation

Articles and Publications

UMIN-ID

jRCT
jRCT1040250125

Memo

COI Disclosure

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