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

NCT ID: NCT07052734

Last Updated: 2025-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2843 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-06-18

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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wang shusen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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BC-MRS-01

Identifier Type: -

Identifier Source: org_study_id

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