Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients (BC-MRS-01)

Sun Yat-sen University

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07052734

BC-MRS-01

Details and patient eligibility

About

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

Enrollment: 2,843 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.