Age
Item
male or female ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma epithelial TNM Breast tumor staging
Item
histologically confirmed stage i-iii epithelial breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Operation on breast | Axilla Operative Surgical Procedures
Item
adequate surgery of breast and axilla:
boolean
C3714726 (UMLS CUI [1])
C0004454 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Total mastectomy | Breast-Conserving Surgery
Item
1. patients must have undergone either a total mastectomy or breast conserving surgery
boolean
C0024886 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
Specimen Resected | Surgical margins Free of Invasive cancer
Item
2. surgical margins of the resected specimen must be histologically free of invasive tumor.
boolean
C0370003 (UMLS CUI [1,1])
C1521996 (UMLS CUI [1,2])
C0229985 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0677898 (UMLS CUI [2,3])
Informed Consent
Item
signed informed consent obtained prior to any study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma epithelial TNM Breast tumor staging
Item
histologically confirmed stage 0 epithelial breast cancer (carcinoma in situ).
boolean
C0678222 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Histology High risk of Relapse | Histology Low Risk Relapse | Sarcoma | Carcinoma, Tubular
Item
special histologies with a high or low risk of relapse (i.e. sarcoma and tubular carcinoma)
boolean
C4048239 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
C4048239 (UMLS CUI [2,1])
C3538919 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
C1261473 (UMLS CUI [3])
C0205645 (UMLS CUI [4])
Malignant Neoplasms TNM Breast tumor staging | Estrogen Receptor Measurement | Progesterone Receptor Measurement | HER2 Negative | Ki67 Measurement
Item
t1a and t1b tumors with all the following characteristics: g1-2 and n0 and re > 10%, rpg > 10% and her2 negative and ki67≤14%
boolean
C0006826 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C3811131 (UMLS CUI [2])
C3889640 (UMLS CUI [3])
C2348908 (UMLS CUI [4])
C4049944 (UMLS CUI [5])
Distant metastasis
Item
evidence of distant metastases
boolean
C1269798 (UMLS CUI [1])
Study Subject Participation Status | Requirement Follow-up Special
Item
patients participating to other clinical trials requiring follow-up not equal to standard
boolean
C2348568 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0205555 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated | Exception Uterine Cancer TNM clinical staging Treated
Item
previous history of cancer within 5 years from randomization (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage i uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0153567 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])