Postmenopausal state | Early-Stage Breast Carcinoma Hormone Receptor Positive
Item
1. postmenopausal women with hr+ early stage breast cancer at the time of initial diagnosis. for study purposes, postmenopausal is defined as:
boolean
C0232970 (UMLS CUI [1])
C2986665 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Age | Amenorrhea Duration
Item
age ≥ 50 y and amenorrheic for 12 or more months.
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Age | Amenorrhea Duration | Status post Adjuvant Chemotherapy
Item
age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0085533 (UMLS CUI [3,2])
Age | Amenorrhea Duration
Item
age < 50 y and amenorrheic for 12 or more months.
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Bilateral oophorectomy
Item
prior bilateral oophorectomy.
boolean
C0278321 (UMLS CUI [1])
Hysterectomy | Follicle stimulating hormone measurement Postmenopausal state | Luteinizing hormone measurement Postmenopausal state | Estradiol measurement Postmenopausal state
Item
prior hysterectomy and has postmenopausal levels of fsh, lh, and estradiol as per local institutional standards.
boolean
C0020699 (UMLS CUI [1])
C0202022 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C0202123 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
C0337434 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
Age | Hysterectomy
Item
age > 55 y and prior hysterectomy.
boolean
C0001779 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
Intolerance to Anastrozole | Anastrozole Discontinue | Adjuvant therapy Early-Stage Breast Carcinoma Hormone Receptor Positive | Arthralgia CTCAE Grades | Myalgia CTCAE Grades
Item
2. patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for hr+ early stage breast cancer due to grade 2-3 (nci-ctcae v3) arthralgia-myalgia.
boolean
C1744706 (UMLS CUI [1,1])
C0290883 (UMLS CUI [1,2])
C0290883 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3,1])
C2986665 (UMLS CUI [3,2])
C0019929 (UMLS CUI [3,3])
C1514241 (UMLS CUI [3,4])
C0003862 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
C0231528 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Hormone receptor positive tumor
Item
3. hormone receptor-positive tumors as defined by institutional standards.
boolean
C1563119 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
5. consent to participate in the trial. -
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Secondary malignant neoplasm of female breast Hormone Receptor Positive | Breast cancer recurrent Locally | Exception Chest wall Disease recurrence | Systemic disease Absent
Item
1. postmenopausal women with hr+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.
boolean
C0232970 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0278493 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0205076 (UMLS CUI [4,2])
C0679254 (UMLS CUI [4,3])
C0442893 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Pain Associated with Bone Fracture
Item
2. recent history of pain associated with non-traumatic bone fracture.
boolean
C0030193 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0016658 (UMLS CUI [1,3])
Pain Requirement Analgesics chronic
Item
3. pain requiring chronic use of analgesics (due to any reason).
boolean
C0030193 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002771 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
Collagen Disease | Exception Osteoarthritis
Item
4. history of rheumatological disease except osteoarthritis.
boolean
C0009326 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Hormone Therapy | Aromatase Inhibitors | Exception Anastrozole
Item
5. prior hormonal therapy with ais other than anastrozole.
boolean
C0279025 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0290883 (UMLS CUI [3,2])
Hormone replacement therapy Systemic | Exception Estring | Exception Vagifem | Exception Vaginal estrogens Low dose
Item
6. systemic hormone replacement therapy (hrt) less than 4 weeks before study entry other than estring®, vagifem® or low dose estrogen vaginal cream.
boolean
C0282402 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0591465 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0592238 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1875126 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
Comorbidity Affecting Quality of life
Item
7. concomitant disease which significantly affects quality of life.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,3])
Questionnaire Self-Administered Completion Unable
Item
8. patient unable to complete self administered questionnaire.
boolean
C0034394 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Informed Consent Unable
Item
9. patients unable to sign consent form.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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])