Clinical trial · Observational
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
NCT07052734CI-TRIAL-00091805BC-MRS-01completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 10 years
- description
- 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 (2)
- measure
- Overall survival
- timeFrame
- 10 years
- description
- Overall survival is defined as the duration from the completion of curative surgery until death from any cause.
- measure
- Distant relapse-free survival
- timeFrame
- 10 years
- description
- Distant relapse-free survival is defined as the duration from the completion of curative surgery until distant relapse of the breast cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.