Clinical trial · Observational
Usefulness of Ki67 Index in Hormone Receptor-positive Breast Cancer
Usefulness of Ki67 Proliferative Index to Predict Recurrence and Benefit From Adjuvant Chemotherapy in Hormone Receptor (HR)-Positive Breast Cancer
- 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)
Gene expression studies have identified at least four molecularly distinct subtypes of breast cancer including two biologically distinct ER-positive subtypes of breast cancer: luminal A and luminal B (with luminal B tumors having poorer outcomes than luminal A tumors). Although some luminal B tumors can be identified by their expression of HER2, the major biological distinction between luminal A and B is the proliferation signatures, including genes such as CCNB1, MKI67, and MYBL2, which have higher expression in luminal B tumors than in luminal A tumors. The high cost of gene expression profiling has limited its incorporation into general clinical practice. To date, there is no available IHC-based surrogate assay that can distinguish between luminal A and luminal B tumors. We hypothesized that the IHC determination of the Ki67 index as well as ER, PgR, and HER2 status is able to distinguish the luminal B subtype of breast cancers from the luminal A subgroup.
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
Design
Arms and outcomes
Arms (1)
- label
- hormone receptor-positive breast cancer
- description
- postoperative hormone receptor-positive breast cancer
Primary outcomes (1)
- measure
- to validate Ki67 index to predict recurrence
- timeFrame
- from the date of diagnosis to the date of relapse
Secondary outcomes (1)
- measure
- to investigate cut-off value of Ki67 index
- timeFrame
- from the date of diagnosis to the date of relapse
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * hormone receptor-positive breast cancer patient who received curative surgery from 2004 to 2007 at Samsung Medical Center Exclusion Criteria: * the patients who received neoadjuvant chemotherapy the patients whose biopsy showed DCIS the patients who were not available immunohistochemical findings the patients who were not available medical record
References
Publications (1)
- DERIVEDPark YH, Im SA, Cho EY, Ahn JH, Woo SY, Kim S, Keam B, Lee JE, Han W, Nam SJ, Park IA, Noh DY, Yang JH, Ahn JS, Im YH. Validation and comparison of CS-IHC4 scores with a nomogram to predict recurrence in hormone receptor-positive breast cancers. Oncology. 2014;86(5-6):279-88. doi: 10.1159/000362281. Epub 2014 Jun 4. PMID 24903080