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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Disease-free survival

Time frame: 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 outcomes

Overall survival

Time frame: 10 years

Overall survival is defined as the duration from the completion of curative surgery until death from any cause.
Distant relapse-free survival

Time frame: 10 years

Distant relapse-free survival is defined as the duration from the completion of curative surgery until distant relapse of the breast cancer.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: BC-MRS-01

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 6, 2025
Registry last updated: Jul 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed