Gender | Age
Item
female > 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written and voluntary informed consent understood signed and dated
boolean
C0021430 (UMLS CUI [1])
Breast adenocarcinoma Invasive Measurable | Breast adenocarcinoma Amenable Curative treatment
Item
histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast, amenable to curative therapy.
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0858252 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
Postmenopausal state
Item
patients must be postmenopausal as defined by criteria in appendix 1.
boolean
C0232970 (UMLS CUI [1])
Breast Carcinoma Estrogen receptor positive Immunohistochemistry
Item
breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
boolean
C0678222 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
Exclusion Tamoxifen Hormone Therapy
Item
prior endocrine tamoxifen therapy is not allowed
boolean
C2828389 (UMLS CUI [1,1])
C0039286 (UMLS CUI [1,2])
C0279025 (UMLS CUI [1,3])
Hormone preparation Absent | Hormone replacement therapy To be stopped
Item
patients are not previously treated with an endocrine agent or hormone replacement therapy needs being stopped for at least 6 months.
boolean
C0019932 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0282402 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Prior Chemotherapy | Prior radiation therapy
Item
prior chemotherapy and radiotherapy is allowed
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Serum alanine aminotransferase measurement | AST serum measurement | Secondary malignant neoplasm of liver
Item
adequate renal and liver function serum creatinine and serum bilirubin ≤ 1.5 x uln serum alt and ast ≤ 2.5 x uln (or ≤ 5 in case of liver metastases)
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C1883008 (UMLS CUI [5])
C1261155 (UMLS CUI [6])
C0494165 (UMLS CUI [7])
Serum calcium measurement
Item
serum calcium should be ≤ 11,6 mg/dl
boolean
C0728876 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0,1,2 (appendix 2)
boolean
C1520224 (UMLS CUI [1])
Gender
Item
male
boolean
C0079399 (UMLS CUI [1])
Life threatening illness Requirement Response quick | Hepatic Involvement Extensive | Pulmonary involvement Extensive
Item
life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
boolean
C3846017 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0456962 (UMLS CUI [1,4])
C0441932 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C0748159 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
Hormone Therapy | Hormone replacement therapy
Item
use of any endocrine treatment or recent/current use of hormone replacement therapy.
boolean
C0279025 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
Medical contraindication Tamoxifen | Deep Vein Thrombosis | Vaginal Hemorrhage Unknown origin
Item
contra indication for tamoxifen: history of dvt/vaginal bleeding of unknown origin
boolean
C1301624 (UMLS CUI [1,1])
C0039286 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
C2979982 (UMLS CUI [3,1])
C0332240 (UMLS CUI [3,2])
Dementia
Item
dementia
boolean
C0497327 (UMLS CUI [1])
Cancer Other Interferes with Tamoxifen Therapeutic procedure
Item
history of other malignancy that may interfere with at least 6 months of tamoxifen therapy
boolean
C1707251 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0039286 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])