Usefulness of Ki67 Index in Hormone Receptor-positive Breast Cancer

NCT01273415 | Completed

• 1 other identifier: 2010-12-049
• Study Type: observational
• Target: 1,070
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

hormone receptor-positive breast cancer; nomogram; Ki67; Effects of Chemotherapy

Outcome Measures

Primary Outcomes (1)

• to validate Ki67 index to predict recurrence

  from the date of diagnosis to the date of relapse

Secondary Outcomes (1)

• to investigate cut-off value of Ki67 index

  from the date of diagnosis to the date of relapse

Study Arms (1)

hormone receptor-positive breast cancer

postoperative hormone receptor-positive breast cancer

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

postoperative hormone receptor-positive breast cancer patients from 2004 to 2007 at Samsung Medical Center

You may qualify if:

• hormone receptor-positive breast cancer patient who received curative surgery from 2004 to 2007 at Samsung Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Park 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Young-Hyuck Im, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 10, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

KR (1)