Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients

A Multicenter Retrospective Analysis of the Miti-gene Recurrence Score in Early-Stage Invasive HR-Positive, HER2-Negative Breast Cancer in China

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07052734

Acronym

BC-MRS-01

Enrollment

2843

Registered

2025-07-06

Start date

2024-12-01

Completion date

2025-06-18

Last updated

2025-07-06

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

Conditions

Breast Cancer

Brief summary

Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Diagnosed age: 18-75 years. 2. Early-stage invasive breast cancer, pN0-1. 3. Molecular subtype: HR-positive (ER and/or PR positive), HER2-negative. 4. At least five years of follow-up records (including cases with disease progression within five years and documented records). 5. Sufficient FFPE samples for sectioning or frozen samples for RNA extraction and subsequent testing.

Exclusion criteria

1. FFPE samples with tumor content \<20%, and inability to enrich tumor regions through cutting. 2. Insufficient extracted nucleic acid quantity or severe degradation preventing further experiments. 3. Failure in RT-PCR amplification of housekeeping genes. 4. Multiple primary breast cancers or a history of ipsilateral or contralateral breast cancer. 5. Disease progression unrelated to breast cancer. 6. Lack of prior signed consent for retrospective scientific research or exemption from informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	10 years	Disease-Free Survival (DFS) is defined as the duration from the completion of curative surgery until the first occurrence of any of the following events: local or distant relapse of the breast cancer, development of a new primary cancer, or death from any cause.

Secondary

Measure	Time frame	Description
Overall survival	10 years	Overall survival is defined as the duration from the completion of curative surgery until death from any cause.
Distant relapse-free survival	10 years	Distant relapse-free survival is defined as the duration from the completion of curative surgery until distant relapse of the breast cancer.

Countries

China

Outcome results