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Usefulness of Ki67 Index in Hormone Receptor-positive Breast Cancer

NCT01273415 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1070

Last updated 2017-05-01

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Young-Hyuck Im, M.D., Ph.D. · Samsung Medical Center

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01273415 on ClinicalTrials.gov