Postmenopausal state | Compliance behavior Study Protocol | Primary invasive malignant neoplasm of female breast | Core needle biopsy | Estrogen receptor positive tumor | Progesterone receptor positive tumor | biopsy immunohistochemistry | Epithelial Cells Malignant Positive
Item
1. postmenopausal woman able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.
boolean
C0232970 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C4076461 (UMLS CUI [3])
C1318309 (UMLS CUI [4])
C1562312 (UMLS CUI [5])
C1562928 (UMLS CUI [6])
C2210384 (UMLS CUI [7])
C0014597 (UMLS CUI [8,1])
C0205282 (UMLS CUI [8,2])
C1446409 (UMLS CUI [8,3])
TNM clinical staging
Item
2. clinical stage *t2, t3, t4a,b,c, n0, 1 or 2, m0
boolean
C3258246 (UMLS CUI [1])
Tumor stage T2 | eligible Breast-Conserving Surgery
Item
clinical stage t2 tumors which in the investigators opinion would not be eligible for breast-conserving surgery.
boolean
C0475373 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
Postmenopausal state
Item
3. post menopausal status defined by one of the following:
boolean
C0232970 (UMLS CUI [1])
Menstruation Spontaneous | Age
Item
no spontaneous menses for at least 1 year, in women > 55 years.
boolean
C0025344 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Menses Spontaneous | Amenorrhea | Age | Hysterectomy Related Spontaneous | Hysterectomy Secondary to | gonadotrophin level Postmenopausal | Luteinizing hormone measurement | Follicle stimulating hormone measurement | Estradiol level Postmenopausal
Item
spontaneous menses within the past 1 year but amenorrhoeic in women ≤ 55 years (e.g. spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (lh y fsh levels > 40 iu/l) or postmenopausal estradiol levels (< 5 ng/dl) or according to the definition of "postmenopausal range" for the laboratory involved.
boolean
C0025344 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0002453 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0020699 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0205359 (UMLS CUI [4,3])
C0020699 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0542494 (UMLS CUI [6,1])
C0232970 (UMLS CUI [6,2])
C0202123 (UMLS CUI [7])
C0202022 (UMLS CUI [8])
C1443016 (UMLS CUI [9,1])
C0232970 (UMLS CUI [9,2])
Bilateral oophorectomy
Item
bilateral oophorectomy. (prior to the diagnosis of breast cancer).
boolean
C0278321 (UMLS CUI [1])
Measurable Disease | examination; clinical | Mammography | Ultrasonics (sound)
Item
4. tumor measurable by clinical examination, mammography and ultrasound.
boolean
C1513041 (UMLS CUI [1])
C1456356 (UMLS CUI [2])
C0024671 (UMLS CUI [3])
C1456803 (UMLS CUI [4])
letrozole | Tamoxifen
Item
1. prior treatment with letrozole or tamoxifen.
boolean
C0246421 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
Endocrine System Diseases Uncontrolled | Diabetes Mellitus | Hypothyroidism | Hyperthyroidism | Cushing Syndrome | Addison Disease
Item
2. uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, cushing's syndrome, addison's disease (treated or untreated).
boolean
C0014130 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C0010481 (UMLS CUI [5])
C0001403 (UMLS CUI [6])
Angina, Unstable | Heart Diseases Uncontrolled | New York Heart Association Classification
Item
3. patients with unstable, angina, or uncontrolled cardiac disease (e.g. class iii or iv new york heart association's functional classification).
boolean
C0002965 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1275491 (UMLS CUI [3])
bilateral breast cancer
Item
4. patients with bilateral breast tumors
boolean
C0281267 (UMLS CUI [1])
Patients eligible Breast-Conserving Surgery
Item
5. patients who are eligible for breast conserving surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0917927 (UMLS CUI [1,3])
Inflammatory Breast Carcinoma Evidence | Distant metastasis Evidence
Item
6. evidence of inflammatory breast cancer or distant metastasis.
boolean
C0278601 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1275402 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C0243161 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])