None listed
Conditions
Interventions
None listed
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients willing to provide written informed content to agree to take part in this study; 2) Adult females aged 19 years and above when they give informed consent; 3) Patients with histologically or cytologically confirmed neoplastic primary breast cancer; 4) Patients who have undergone the curative surgery; 5) Patients with negative margins for pathological surgery; 6) Patients at anatomic stage I or II according to AJCC 7th or 8th Edition prognostic stage group criteria; 7) Patients with a lymph node stage of pN0 or pN1; 8) Histologically hormone receptor-positive (estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive) patients; 9) Histologically HER2-negative patients; 10) Patients of which tissue samples collected from surgery are eligible for the GenesWell BCT assay: - tumor block accounts for at least 15% of the total tissue sectioned for screening; or - tumor block has a surface area of at least 3 mm2 in the tissue sectioned for screening.
Exclusion criteria
Exclusion criteria: 1) Patients with recurrent breast cancer; 2) Presence of secondary primary malignancy during a period from five (5) years prior to the screening visit to the enrollment visit (history of secondary primary malignancy, other than non-melanoma skin cancer (NMSC) or localized cervical carcinoma, which has been successfully treated); 3) Patients who have received neoadjuvant chemotherapy, endocrine therapy or radiation therapy prior to the surgical intervention to collect tumor samples; 4) Patients who are not in anatomic stage I or II according to AJCC 7th or 8th Edition prognostic stage group criteria; 5) Patients with a lymph node stage of pN2 or pN3; 6) Hormone receptor-negative (ER- and PR-) patients; 7) Patients who have not undergone the HER2 assay or HER2-positive patients; 8) When GenesWell BCT screening is performed on human-derived materials collected by a method other than surgery; 9) When tissue specimens are not eligible for the GenesWell BCT assay in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of 10-year distant metastasis-free survival (DMFS) rates between GenesWell BCT risk groups (high and low) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of 10-year disease-free survival (DFS) rates between GenesWell BCT risk groups (high and low);Comparison of 10-year overall survival (OS) rates between GenesWell BCT risk groups (high and low);Comparison of 10-year DMFS rates between GenesWell BCT risk groups (high and low) according to whether patients have undergone post-surgery chemotherapy;Comparison of 10-year DFS rates between GenesWell BCT risk groups (high and low) according to whether patients have undergone post-surgery chemotherapy;Comparison of 10-year OS rates between GenesWell BCT risk groups (high and low) according to whether patients have undergone post-surgery chemotherapy;Interim assessment of 1-year DMFS rate, 1-year DFS rate and 1-year OS rate by GenesWell BCT risk group (high and low);Interim assessment of 3-year DMFS rate, 3-year DFS rate and 3-year OS rate by GenesWell BCT risk group (high and low);Comparison of 10-year DMFS rates, 10-year DFS rates and 10-year OS rates between GenesWell BCT risk groups (high and low) according to a stage at surgery (anatomic stage I/II);Assessment of sensitivity, specificity, positive predictive value, and negative predictive value for distant metastasis onset within 10 years with GenesWell BCT assay;Comparison between categorizations by GenesWell BCT assay and by clinical risk (C-risk);Comparison of 10-year DMFS rates between GenesWell BCT risk groups (high and low) by age group (e.g. with age intervals as large as 10 years, such as 30s, 40s, 50s and 60s) | — |
Countries
Korea, Republic of
Contacts
Public Contactsang uk woo
Korea University
Outcome results
None listed