Postmenopausal state | Invasive carcinoma of breast Primary Core needle biopsy | Estrogen receptor positive tumor | Progesterone receptor positive tumor
Item
postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive
boolean
C0232970 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
C1562312 (UMLS CUI [3])
C1562928 (UMLS CUI [4])
Tumor size TNM clinical staging | Tumor size Measurable Mammography | Target Lesion Identification
Item
clinical stage t1c (size ≥ 1.5 cm), t2, t3, t4a, b, c, n0 or n1, m0 (tnm classification). according to the modified recist criteria, tumors of size ≥ 1.5 cm are considered measurable by mammography and can be determined as target lesions).
boolean
C0475440 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C0024671 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3])
Neoplasm Measurable Mammography | Ultrasonography | Physical Examination
Item
tumor measurable by mammography, sonography and clinical examination.
boolean
C0027651 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal and hepatic function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
health good ECOG performance status
Item
good health status (ecog performance status of 0, 1 or 2)
boolean
C1277245 (UMLS CUI [1,1])
C1520224 (UMLS CUI [1,2])
letrozole | Diphosphonates | Breast Cancer Therapeutic Procedure | Chemotherapy | Immunotherapy | Biological Response Modifier Therapy | Hormone Therapy | Steroids | Therapeutic radiology procedure | Hormone replacement therapy
Item
prior treatment with letrozole or bisphosphonates. prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (brm's), endocrine therapy other than letrozole (including steroids), and radiotherapy. patients who have received hormone replacement therapy (hrt) will not be excluded, provided that hrt is discontinued at least 2 weeks prior to entry into the study.
boolean
C0246421 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
C1511300 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0005527 (UMLS CUI [6])
C0279025 (UMLS CUI [7])
C0038317 (UMLS CUI [8])
C1522449 (UMLS CUI [9])
C0282402 (UMLS CUI [10])
Angina, Unstable | Heart Disease Uncontrolled New York Heart Association Classification | Endocrine System Disease Uncontrolled
Item
patients with unstable angina, or uncontrolled cardiac disease (e.g. class iii and iv new york heart association's functional classification, see appendix 9) or uncontrolled endocrine disorders.
boolean
C0002965 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0014130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Inflammatory Breast Carcinoma Evidence of | Distant metastasis
Item
evidence of inflammatory breast cancer or distant metastasis.
boolean
C0278601 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1275402 (UMLS CUI [2])
Tooth problem | Infection of tooth | Jaw infection Maxilla | Jaw infection Mandible | Dental trauma | Osteonecrosis of jaw | exposed bone of oral vestibule | Dental Procedure Healing Slow | Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implantation
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3,1])
C0024947 (UMLS CUI [3,2])
C1400570 (UMLS CUI [4,1])
C0024687 (UMLS CUI [4,2])
C1301685 (UMLS CUI [5])
C2711248 (UMLS CUI [6])
C2013525 (UMLS CUI [7])
C0011331 (UMLS CUI [8,1])
C0043240 (UMLS CUI [8,2])
C0439834 (UMLS CUI [8,3])
C0204324 (UMLS CUI [9])
C0407713 (UMLS CUI [10])
C0040440 (UMLS CUI [11])
C0011370 (UMLS CUI [12])
Disease Affecting bone metabolism | Paget's Disease | Osteogenesis Imperfecta | Primary Hyperthyroidism | Secondary hyperthyroidism
Item
history of diseases with influence on bone metabolism, such as paget's disease, osteogenesis imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C1368019 (UMLS CUI [2])
C0029434 (UMLS CUI [3])
C3714618 (UMLS CUI [4])
C1095928 (UMLS CUI [5])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])