Breast Carcinoma | Postmenopausal state | Age | Tumor tissue sample Primary Estrogen receptor positive | Tumor tissue sample Primary Progesterone receptor positive | Tumor tissue sample metastatic Estrogen receptor positive | Tumor tissue sample metastatic Progesterone receptor positive
Item
histological confirmation of breast cancer in post menopausal women (age >=60). positive hormone receptor status (er +ve and/or pgr +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
boolean
C0678222 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0475358 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C0279754 (UMLS CUI [4,3])
C0475358 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C0279759 (UMLS CUI [5,3])
C0475358 (UMLS CUI [6,1])
C1522484 (UMLS CUI [6,2])
C0279754 (UMLS CUI [6,3])
C0475358 (UMLS CUI [7,1])
C1522484 (UMLS CUI [7,2])
C0279759 (UMLS CUI [7,3])
Advanced disease Locally | Neoplasm Metastasis
Item
either locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) or metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
Measurable lesion Quantity | Non-Measurable Lesion Quantity | Lesion Assessment
Item
at least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Postmenopausal state
Item
postmenopausal women, fulfilling 1 of:
boolean
C0232970 (UMLS CUI [1])
Bilateral oophorectomy Previous
Item
prior bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Age
Item
age >60 years
boolean
C0001779 (UMLS CUI [1])
Age | Amenorrhea Duration | Chemotherapy Absent | Tamoxifen Absent | Toremifene Absent | Ovarian suppression Absent | Follicle Stimulating Hormone Consistent with Postmenopausal state | Estradiol Consistent with Postmenopausal state
Item
age < 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and fsh and oestradiol in the postmenopausal range
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0076836 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0677922 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0733758 (UMLS CUI [7,1])
C0332290 (UMLS CUI [7,2])
C0232970 (UMLS CUI [7,3])
C0014912 (UMLS CUI [8,1])
C0332290 (UMLS CUI [8,2])
C0232970 (UMLS CUI [8,3])
Neoplasm Metastasis Life Threatening
Item
presence of life-threatening metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Exclusion Criteria Any
Item
any of:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Hepatic Involvement Extensive
Item
extensive hepatic involvement
boolean
C0441932 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
Brain Involving | Meninges Involving
Item
involving brain or meninges
boolean
C0006104 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0025285 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Pulmonary lymph node Spread Symptomatic
Item
symptomatic pulmonary lymph spread
boolean
C0229749 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Secondary malignant neoplasm of lung Discrete Acceptable
Item
discrete lung metastases are acceptable if respiratory function is not significantly compromised
boolean
C0153676 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
Systemic therapy Previous Breast Carcinoma | Exception Cytotoxic Chemotherapy
Item
prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
Therapeutic radiology procedure Incomplete | Prior Hormone Therapy Breast Carcinoma
Item
radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). prior hormonal treatment for breast cancer.
boolean
C1522449 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])