Clinical performance study of breast cancer prognostic diagnosticsGenesWell™ BCT in Korean patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004263
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1.1. Selection criteria
1.1.1. Criteria for Selection of Sample Providers
1) hormone receptor positive (ER+ and/or PR+)
2) Human epidermal growth factor receptor type2 negative (HER2-)
3) pN0 or pN1 is applicable
4) Female patients

1.1.2. Criteria for selecting remaining samples
1) Residual samples containing the collected tissue with paraffin (FFPE residual samples)
2) In case pathological samples that are not obstructed in future care are stored

Exclusion Criteria

1.1.1. Exclusion Criteria for Sample Providers
1) For hormone receptor negative (ER- and PR-)
2) Human epidermal growth factor receptor type2 (HER2+)
3) pN2, or pN3 is applicable

1.1.2. Exclusion Criteria for Residual Specimens
1) Remaining samples not covered with paraffin (non-FFPE residual samples)
2) Pathologists have determined that the condition of the FFPE block is not available for clinical trials in tissue and pathology

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distant metastasis free survival

Secondary Outcome Measures

Name	Time	Method
Disease free survival;overall survival;Breast cancer specific survival