Post marketing surveillance on GenesWell BCT (Prognostic test for early breast cancer patient based on the gene expression signature through the algorithm) with Early Breast Cancer

Not Applicable

Active, not recruiting

Conditions: Neoplasms

Registration Number: KCT0006976

Lead Sponsor: Koera University Guro Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: Female

Target Recruitment: 600

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

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.