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JBCRG-C12 (PROGRESS study)

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" (PROGRESS study) - JBCRG-C12 (PROGRESS study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1040250125
Enrollment
5000
Registered
2025-11-05
Start date
2025-11-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early breast cancer that is ER-positive and HER2-negative Early breast cancer that is ER-positive and HER2-negative

Interventions

None listed

Sponsors

Koizumi Kei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older. 2.Patients who underwent Oncotype DX Breast Recurrence Score testing through the Oncotype DX Breast Recurrence Score Testing Program and had their recurrence score measured. 3.Patients with ER-positive, HER2-negative early-stage breast cancer who had no lymph node metastasis or 1-3 positive lymph nodes.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent Oncotype DX Breast Recurrence Score testing through the Oncotype DX Breast Recurrence Score Program but whose recurrence scores were not measured or were unknown. 2. Patients who did not give their consent or withdrew their consent from the study. 3. Patients with bilateral breast cancer.

Design outcomes

Primary

MeasureTime frame
Invasive disease free survival: iDFS

Secondary

MeasureTime frame
-Overall survival (OS) -Disease-free survival (DFS) -Distant disease-free survival (DDFS) -Distribution of recurrence scores based on clinical pathological factors in the entire group that underwent Oncotype DX and treatment selection -Treatment selection status and prognosis, including the proportion of chemotherapy administration by recurrence score -Correlation between Oncotype DX recurrence score and OS, DFS, and DDFS with S-1 administration -Correlation between Oncotype DX recurrence score and iDFS, OS, DFS, and DDFS with abemaciclib administration -Treatment completion rate and reasons for discontinuation

Contacts

Public ContactKei Koizumi

Hamamatsu University Hospital

koizumi@hama-med.ac.jp+81-53-435-2276

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026