Estrogen receptor positive Human epidermal growth factor 2 negative carcinoma of breast Adenocarcinoma
Item
documentation of histological or cytological confirmation of estrogen receptor positive (er+) and her2 negative adenocarcinoma of the breast must be available.
boolean
C0279754 (UMLS CUI [1,1])
C2316304 (UMLS CUI [1,2])
C0001418 (UMLS CUI [1,3])
Gender | Age | Carcinoma breast stage IV | curative treatment | Operative Surgical Procedures | Therapeutic radiology procedure
Item
women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0278488 (UMLS CUI [3])
C1273390 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
Menopausal Status | Postmenopausal state | Premenopausal
Item
documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
boolean
C1513126 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0279752 (UMLS CUI [3])
Bone Diseases | Neoplasm Metastasis Soft tissue Lymph nodes | Neoplasm Metastasis Skeletal | Bone scintigraphy X-Ray Computed Tomography Magnetic Resonance Imaging
Item
subjects with bone dominant disease (with or without metastases in soft tissue including lymph nodes) with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by computed tomography (ct)/magnetic resonance imaging (mri).
boolean
C0005940 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0225317 (UMLS CUI [2,2])
C0024204 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0521324 (UMLS CUI [3,2])
C3889015 (UMLS CUI [4,1])
C0040405 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Measurable Disease | Non-Measurable Tumor Identification | Evaluation procedure Radiologic | Response Evaluation Criteria in Solid Tumors
Item
measurable or non-measurable disease (but radiologically evaluable) according to response evaluation criteria in solid tumors (recist) v1.1 criteria.
boolean
C1513041 (UMLS CUI [1])
C3538912 (UMLS CUI [2])
C1261322 (UMLS CUI [3,1])
C0205483 (UMLS CUI [3,2])
C1709926 (UMLS CUI [4])
Hormone Therapy Metastatic Neoplasm
Item
subjects must have received at least one line of hormonal therapy in the metastatic setting
boolean
C0279025 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
Standard of Care Therapeutic procedure Endocrine system
Item
subjects who are eligible for further standard of care endocrine treatment.
boolean
C2936643 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0014136 (UMLS CUI [1,3])
Hormone preparation Singular | RADIUM CHLORIDE RA-223
Item
subjects enrolled in the current study will start treatment with the single hormone agent after randomization either before or simultaneously to the first injection of ra-223. patients already receiving the single agent hormone treatment prior to study entry are not eligible. combination hormonal treatment is not allowed.
boolean
C0019928 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C3541342 (UMLS CUI [2])
Skeletal Event | Teleradiotherapy procedure Bone pain | Pathological bone fracture | Major injury | Compression of spinal cord | Orthopedic Surgical Procedures
Item
subjects must have experienced no more than two skeletal-related events (sres) prior to study entry defined as: external beam radiotherapy (ebrt) for bone pain, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. subjects with no prior sres are not permitted.
boolean
C0521324 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0419095 (UMLS CUI [2,1])
C0151825 (UMLS CUI [2,2])
C1718193 (UMLS CUI [3])
C0332677 (UMLS CUI [4])
C0037926 (UMLS CUI [5])
C1136201 (UMLS CUI [6])
Therapeutic procedure Diphosphonates | Denosumab therapy
Item
subjects must be on therapy with bisphosphonate and denosumab. and are required to have been on such therapy for at least 3 months before start of study treatment.
boolean
C0087111 (UMLS CUI [1,1])
C0012544 (UMLS CUI [1,2])
C3839270 (UMLS CUI [2])
Breast Carcinoma Asymptomatic | Breast Carcinoma Symptomatic Mild
Item
asymptomatic or mildly symptomatic breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C2945599 (UMLS CUI [2,3])
Hematologic function Adequate | Normal liver function | Normal renal function
Item
adequate hematological, liver and kidney function
boolean
C0221130 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C1848676 (UMLS CUI [2])
C0232805 (UMLS CUI [3])
Malignant Neoplasms Following
Item
subjects with any of the following cancers:
boolean
C0006826 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
bilateral breast cancer | Two Malignant Neoplasms
Item
bilateral breast cancer or a history of 2 distinct breast cancers.
boolean
C0281267 (UMLS CUI [1])
C0205448 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Neoplasm Metastasis Visceral
Item
history and/or presence of confirmed visceral metastases.
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
Chemotherapy Regimen Neoplasm Metastasis | Chemotherapy Regimen Carcinoma breast stage IV | Adjuvant therapy | Neoadjuvant Therapy
Item
subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. chemotherapy administered for adjuvant/neo adjuvant disease is acceptable provided it was administered at least 1 year prior to study entry.
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0278488 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3])
C0600558 (UMLS CUI [4])
Metastatic malignant neoplasm to brain | Leptomeningeal disease | Neurologic Symptoms | ct scan contrast Entire brain | Magnetic Resonance Imaging Entire brain | Central Nervous System Imaging Techniques
Item
subjects with known or history of brain metastases or leptomeningeal disease: subjects with neurological symptoms must undergo a contrast ct scan or mri of the brain within 28 days prior to randomization to exclude active brain metastasis. imaging of the central nervous system (cns) is otherwise not required.
boolean
C0220650 (UMLS CUI [1])
C3160796 (UMLS CUI [2])
C0235031 (UMLS CUI [3])
C0742919 (UMLS CUI [4,1])
C1269537 (UMLS CUI [4,2])
C0024485 (UMLS CUI [5,1])
C1269537 (UMLS CUI [5,2])
C3714787 (UMLS CUI [6,1])
C0079595 (UMLS CUI [6,2])