Age
Item
age 18 years of age
boolean
C0001779 (UMLS CUI [1])
Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Breast Carcinoma incurable | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer.
boolean
C2938924 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0678222 (UMLS CUI [3,1])
C0175969 (UMLS CUI [3,2])
C3495949 (UMLS CUI [4])
C0346993 (UMLS CUI [5])
Disease Progression | Non-Steroidal Aromatase Inhibitor Advanced disease Local | Non-Steroidal Aromatase Inhibitor Neoplasm Metastasis | Recurrent disease | Discontinuation Adjuvant therapy
Item
must have disease progression during treatment with a nonsteroidal ai for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting.
boolean
C0242656 (UMLS CUI [1])
C1518386 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C1518386 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
C0457454 (UMLS CUI [5,1])
C0677850 (UMLS CUI [5,2])
Postmenopausal state
Item
must be a postmenopausal female.
boolean
C0232970 (UMLS CUI [1])
Measurable Disease | Evaluable Disease
Item
must have measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Measurable Disease | Lesion Quantity Diameter
Item
measurable disease is defined as >=1 lesion with a diameter of >=10 mm
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
Evaluable Disease | Bone lesion Plain x-ray | Bone lesion CT scan | Bone lesion MRI | Radioisotope scan of bone only Excluded
Item
evaluable disease is defined as bone lesions evaluable by plain x ray, ct scan, or mri. lesions identified only by radionuclide bone scan are not allowed.
boolean
C1516986 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C1306645 (UMLS CUI [2,2])
C0238792 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0203668 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C2828389 (UMLS CUI [5,3])
Chemotherapy Quantity Secondary malignant neoplasm of female breast Advanced
Item
one prior chemotherapy regimen for advanced mbc is allowed.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
Prior radiation therapy
Item
prior radiotherapy is allowed.
boolean
C0279134 (UMLS CUI [1])
Able to swallow Oral medication | Ability Retain Oral medication
Item
must be able to swallow and retain oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status of <=2
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Required
Item
required laboratory values
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Plasma cortisol measurement | Adrenocorticotropic hormone measurement | Adrenal gland hypofunction Evidence Lacking | Exception Replacement therapy Adrenal gland hypofunction
Item
plasma cortisol and adrenocorticotropic hormone (acth) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency.
boolean
C1281899 (UMLS CUI [1])
C0201835 (UMLS CUI [2])
C0001623 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279033 (UMLS CUI [4,2])
C0001623 (UMLS CUI [4,3])
Neoplasm HER2 Overexpression
Item
her2 overexpressing tumor.
boolean
C0027651 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
CNS metastases
Item
history of central nervous system (cns) metastasis.
boolean
C0686377 (UMLS CUI [1])
Exemestane | HSP90 Inhibitor
Item
previous treatment with exemestane or treatment with an hsp90 inhibitor.
boolean
C0851344 (UMLS CUI [1])
C0243044 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
Proton Pump Inhibitors
Item
use of proton pump inhibitors.
boolean
C0358591 (UMLS CUI [1])
Hepatitis B | Hepatitis C | HIV Infection | Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity
Item
known history of or positive test result for hepatitis b or c or hiv.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C1608966 (UMLS CUI [4])
C1609517 (UMLS CUI [5])
C0019699 (UMLS CUI [6])
Gastrectomy | Major surgery Small Intestine
Item
history of gastrectomy or major surgery to small intestine.
boolean
C0017118 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0021852 (UMLS CUI [2,2])