Gender | Age | Invasive carcinoma of breast | Invasive Ductal Breast Carcinoma | Tubular breast carcinoma | Mucinous carcinoma of breast | Tumor size Microscopy | Neoplasm Metastasis Absent
Item
1. female patient > or = 55 years of age with a new diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous only) with primary tumour < or =2cm on microscopic exam, with no evidence of metastatic disease;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0853879 (UMLS CUI [3])
C1134719 (UMLS CUI [4])
C1328544 (UMLS CUI [5])
C1334807 (UMLS CUI [6])
C0475440 (UMLS CUI [7,1])
C0026018 (UMLS CUI [7,2])
C0027627 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry | HER2 Negative Immunohistochemistry | Estrogen receptor positive In Situ Hybridization | Progesterone receptor positive In Situ Hybridization | HER2 Negative In Situ Hybridization
Item
2. er positive (> or =1%) and pr positive (>20%) and her2 negative (immunohistochemical (ihc) or in situ hybridization (ish) approach);
boolean
C0279754 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279759 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C2348908 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0279754 (UMLS CUI [4,1])
C0162788 (UMLS CUI [4,2])
C0279759 (UMLS CUI [5,1])
C0162788 (UMLS CUI [5,2])
C2348908 (UMLS CUI [6,1])
C0162788 (UMLS CUI [6,2])
Breast-Conserving Surgery | Surgical margins Length Microscopic | Disease Invasive | Disease Non-invasive | Reexcision | Residual disease Absent
Item
3. treated by bcs with microscopically clear resection margins > or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
boolean
C0917927 (UMLS CUI [1])
C0229985 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C0205288 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205303 (UMLS CUI [4,2])
C0184913 (UMLS CUI [5])
C0543478 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Axillary Lymph Node Involvement Negative Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes
Item
4. negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.
boolean
C0741343 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
C0193867 (UMLS CUI [2])
Disease TNM Breast tumor staging | Extension Chest wall | Skin Involvement | Peau d'orange | Inflammatory Breast Carcinoma
Item
1. clinical or pathological evidence of t4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0231448 (UMLS CUI [2,1])
C0205076 (UMLS CUI [2,2])
C1123023 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0425791 (UMLS CUI [4])
C0278601 (UMLS CUI [5])
Disease Multifocal | Disease Multicentric
Item
2. multifocal or multicentric disease.
boolean
C0012634 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0439743 (UMLS CUI [2,2])
Intraductal tumor configuration Extensive | Tumor Percentage DCIS | Disease Only microinvasion present
Item
3. evidence of an extensive intraductal component (defined as a tumour that is composed of 25% or more of dcis and the dcis extends beyond the gross dimensions of the tumour), or disease limited to micro invasion only.
boolean
C1276434 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0007124 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C4489121 (UMLS CUI [3,2])
Disease Invasive Histology grade
Item
4. grade 3 histology for invasive disease
boolean
C0012634 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1317415 (UMLS CUI [1,3])
Lymphatic Invasion
Item
5. evidence of lymphovascular invasion.
boolean
C1708790 (UMLS CUI [1])
Disease Mammography Preoperative | Breast-Conserving Surgery Primary tumor
Item
6. evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
boolean
C0012634 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0917927 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
Bilateral breast cancer Synchronous | Bilateral breast cancer
Item
7. bilateral malignancy of the breast (synchronous or metachronous).
boolean
C0281267 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C0281267 (UMLS CUI [2])
BRCA1 gene mutation | BRCA2 gene mutation
Item
8. known brca 1 or 2 mutations.
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of endometrium Treated | Exception Colon Carcinoma Treated | Exception Malignant melanoma in situ Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
9. history of non-breast cancer malignancies if not disease free for > 5 years and considered low risk of recurrence with the exception of treated carcinoma in-situ of the cervix, endometrium or colon, melanoma in-situ and basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C3538919 (UMLS CUI [4,2])
C0034897 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0346191 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0699790 (UMLS CUI [7,2])
C1522326 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0854696 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0007117 (UMLS CUI [9,2])
C1522326 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0553723 (UMLS CUI [10,2])
C1522326 (UMLS CUI [10,3])
Disease Serious | Exception Malignant Neoplasm | Life Expectancy
Item
10. serious non-malignant disease associated with a life expectancy < 10 years.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Hormone Therapy Receive Unable
Item
11. inability to be treated with or to tolerate endocrine therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance
Item
12. psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0085281 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Unavailability Follow-up | Etiology Geographic Factors
Item
13. geographic inaccessibility for follow-up.
boolean
C0686905 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0017444 (UMLS CUI [2,2])
Informed Consent Comprehension Unable | Informed Consent Unable
Item
14. inability to understand or unable to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Enrollment Unable | Time Period Operation on breast Last
Item
15. inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
boolean
C1516879 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1948053 (UMLS CUI [2,1])
C3714726 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])
Ki67 Measurement Consistent with Luminal B Subtype of Breast Carcinoma
Item
16. central testing for ki67 > 13.25% consistent with the luminal b subtype
boolean
C4049944 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C3642346 (UMLS CUI [1,3])