Breast Carcinoma
Item
histological diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Excision Breast Carcinoma | Breast-Conserving Surgery | Mastectomy
Item
surgical resection of breast cancer (breast conserving surgery or mastectomy)
boolean
C0728940 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0917927 (UMLS CUI [2])
C0024881 (UMLS CUI [3])
Disease Evidence of
Item
no evidence of disease
boolean
C0012634 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Indication Hormone Therapy Adjuvant | Estrogen receptor positive | progesterone receptor positive | Immunohistochemistry Tumor cells Primary
Item
indication for adjuvant hormonal therapy (er and/or pgr positive with ihc exam in at least 1% of primary tumor cells, according to st. gallen criteria)
boolean
C3146298 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C1522673 (UMLS CUI [1,3])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C0021044 (UMLS CUI [4,1])
C0431085 (UMLS CUI [4,2])
C0205225 (UMLS CUI [4,3])
Age
Item
patient age at least 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Premenopausal | Last menstrual period | Follicle Stimulating Hormone | Luteinizing Hormone | Menopausal Status | Ovarian suppression Reversible Chemotherapy Induced
Item
written informed consent . premenopausal status defined as lmp within 12 months of randomization (fsh, lh will not be considered as determinants of menopausal status due the chemotherapy induced reversible ovarian suppression)
boolean
C0021430 (UMLS CUI [1])
C0279752 (UMLS CUI [2,1])
C0425932 (UMLS CUI [2,2])
C0733758 (UMLS CUI [3])
C0023607 (UMLS CUI [4])
C3829127 (UMLS CUI [5])
C0677922 (UMLS CUI [6,1])
C0205343 (UMLS CUI [6,2])
C0392920 (UMLS CUI [6,3])
C0205263 (UMLS CUI [6,4])
Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Therapeutic radiology procedure Local | Therapeutic radiology procedure regional
Item
please note that patients who have received neoadjuvant or adjuvant chemotherapy and/or locoregional radiation therapy may be included in the study
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205276 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205147 (UMLS CUI [4,2])
ECOG performance status
Item
performance status (ecog)>2.
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma Non-Malignant Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate
Item
previous or concomitant malignancy (with the exception of adequately treated nonmalignant skin cancer and carcinoma in situ of the uterine cervix
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0205411 (UMLS CUI [2,4])
C0851140 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
Carcinoma breast stage IV
Item
metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine > 1.25 times the value of upper normal limit
boolean
C0201976 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Bone Fracture Evidence of
Item
clinical or radiologic evidence of bone fractures
boolean
C0016658 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Cortisone Systemic
Item
treatment with systemic cortisone therapy within 12 months prior to randomization
boolean
C0010137 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Pharmaceutical Preparations Affecting bone metabolism | Calcitonin measurement | Plicamycin | gallium nitrate
Item
treatment with drugs that could alter bone metabolism (calcitonin, mithramycin, gallium nitrate) within 2 weeks prior to randomization
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0201924 (UMLS CUI [2])
C0026234 (UMLS CUI [3])
C0061008 (UMLS CUI [4])
Tamoxifen | Aromatase Inhibitors
Item
previous treatment with tamoxifen or aromatase inhibitors
boolean
C0039286 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Indication Hepatic Insufficiency | letrozole Risk
Item
ast and/or alt > 3 times the value of upper normal limit with clinical and laboratory findings that indicate a grade of hepatic insufficiency that could potentially increase the risk of assuming letrozole
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C1306571 (UMLS CUI [3,2])
C0246421 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
Comorbidity Medical contraindication Investigational New Drugs Use of
Item
any concomitant conditions that would, in the investigator's opinion, contraindicate the use of any of the drugs used in this study
boolean
C0009488 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Follow-up Unable
Item
inability to comply with followup
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Invasive procedure Dental | Invasive procedure Dental Planned
Item
patient undergoing invasive dental work at time of baseline evaluation or foreseen during the course of adjuvant therapy
boolean
C0038895 (UMLS CUI [1,1])
C0226984 (UMLS CUI [1,2])
C0038895 (UMLS CUI [2,1])
C0226984 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])