Carcinoma breast stage IV | Gender | Age | 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
C0278488 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1273390 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
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])
Menopausal Status | Postmenopausal state | Premenopausal - menopausal status | Therapeutic radiology procedure ovarian | Therapeutic procedure Gonadotropin hormone-releasing hormone activity | Estradiol measurement | Pregnancy test negative Contraceptive methods
Item
documentation of menopausal status: postmenopausal subjects are eligible pre-menopausal subjects with ovarian radiation or concomitant treatment with an lh-rf agonist/antagonist must have a plasma/serum estradiol assay of <20 pg/ml at screening within 7 days prior to randomization. negative pregnancy test is also required at screening. agreement to use adequate method of contraception as recommended by their treating physician.
boolean
C3829127 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0279752 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0205065 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C1149487 (UMLS CUI [5,2])
C0337434 (UMLS CUI [6])
C0427780 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
Bone Diseases Neoplasm Metastasis Skeletal Bone scintigraphy | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
subjects with bone dominant disease 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 [1,1])
C0027627 (UMLS CUI [1,2])
C0521324 (UMLS CUI [1,3])
C3889015 (UMLS CUI [1,4])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
Hormone Therapy Neoplasm Metastasis
Item
subjects must have received at least one line of hormonal therapy in the metastatic setting.
boolean
C0279025 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Therapeutic procedure exemestane everolimus | Hormone Therapy Neoplasm Metastasis
Item
subjects who are eligible as per the investigator's assessment and according to the local label for treatment with exemestane and everolimus as a second line or greater of hormone therapy in a metastatic setting.
boolean
C0087111 (UMLS CUI [1,1])
C0851344 (UMLS CUI [1,2])
C0541315 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Recurrent disease | Progressive Disease | Therapeutic procedure Non-Steroidal Aromatase Inhibitor | letrozole | anastrozole | Adjuvant therapy | Neoplasm Metastasis
Item
subjects must have experienced recurrent/progressive disease following treatment with a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or metastatic setting
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1518386 (UMLS CUI [3,2])
C0246421 (UMLS CUI [4])
C0290883 (UMLS CUI [5])
C0677850 (UMLS CUI [6])
C0027627 (UMLS CUI [7])
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 bisphosphonates or denosumab for at least 1 month 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 Mild Symptomatic
Item
asymptomatic or mildly symptomatic breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0231220 (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 Breast Carcinoma
Item
bilateral breast cancer or a history of 2 distinct breast cancers.
boolean
C0281267 (UMLS CUI [1])
C0205448 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Disease Visceral Life Threatening | Chemotherapy Regimen
Item
patients with immediately life-threatening visceral disease for whom chemotherapy is preferred treatment option
boolean
C0012634 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
Chemotherapy Regimen Metastatic Neoplasm | Chemotherapy Regimen Carcinoma breast stage IV
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])
C2939420 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0278488 (UMLS CUI [2,2])
Therapeutic procedure everolimus
Item
subjects who received prior treatment or are already receiving everolimus treatment prior to study entry are not eligible
boolean
C0087111 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Leptomeningeal disease | Neurologic Symptoms | ct scan contrast Entire brain | Magnetic Resonance Imaging Entire brain | Central Nervous System Imaging Technology
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])
C1704382 (UMLS CUI [6,2])