ID

43807

Description

Study of Radium-223 Dichloride Versus Placebo and Treatment With Exemestane / Everolimus in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02258451

Link

https://clinicaltrials.gov/show/NCT02258451

Keywords

Versions (2)
  1. 5/3/16 5/3/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02258451

English

Eligibility Breast Neoplasms NCT02258451

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
Description

Carcinoma breast stage IV | Gender | Age | curative treatment | Operative Surgical Procedures | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C1273390
UMLS CUI [5]
C0543467
UMLS CUI [6]
C1522449
documentation of histological or cytological confirmation of estrogen receptor positive (er+) and her2 negative adenocarcinoma of the breast must be available.
Description

Estrogen receptor positive Human epidermal growth factor 2 negative carcinoma of breast Adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0279754
UMLS CUI [1,2]
C2316304
UMLS CUI [1,3]
C0001418
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C3829127
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0279752
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205065
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1149487
UMLS CUI [6]
C0337434
UMLS CUI [7,1]
C0427780
UMLS CUI [7,2]
C0700589
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).
Description

Bone Diseases Neoplasm Metastasis Skeletal Bone scintigraphy | X-Ray Computed Tomography | Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0005940
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0521324
UMLS CUI [1,4]
C3889015
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
subjects must have received at least one line of hormonal therapy in the metastatic setting.
Description

Hormone Therapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0027627
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.
Description

Therapeutic procedure exemestane everolimus | Hormone Therapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0851344
UMLS CUI [1,3]
C0541315
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0027627
subjects must have experienced recurrent/progressive disease following treatment with a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or metastatic setting
Description

Recurrent disease | Progressive Disease | Therapeutic procedure Non-Steroidal Aromatase Inhibitor | letrozole | anastrozole | Adjuvant therapy | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1518386
UMLS CUI [4]
C0246421
UMLS CUI [5]
C0290883
UMLS CUI [6]
C0677850
UMLS CUI [7]
C0027627
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.
Description

Skeletal Event | Teleradiotherapy procedure Bone pain | Pathological bone fracture | Major injury | Compression of spinal cord | Orthopedic Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0521324
UMLS CUI [1,2]
C0441471
UMLS CUI [2,1]
C0419095
UMLS CUI [2,2]
C0151825
UMLS CUI [3]
C1718193
UMLS CUI [4]
C0332677
UMLS CUI [5]
C0037926
UMLS CUI [6]
C1136201
subjects must be on therapy with bisphosphonates or denosumab for at least 1 month before start of study treatment.
Description

Therapeutic procedure Diphosphonates | Denosumab therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0012544
UMLS CUI [2]
C3839270
asymptomatic or mildly symptomatic breast cancer.
Description

Breast Carcinoma Asymptomatic | Breast Carcinoma Mild Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0231221
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C2945599
UMLS CUI [2,3]
C0231220
adequate hematological, liver and kidney function
Description

Hematologic function Adequate | Normal liver function | Normal renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205411
UMLS CUI [2]
C1848676
UMLS CUI [3]
C0232805
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with any of the following cancers:
Description

Malignant Neoplasms Following

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332282
inflammatory breast cancer
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
bilateral breast cancer or a history of 2 distinct breast cancers.
Description

bilateral breast cancer | Two Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2,1]
C0205448
UMLS CUI [2,2]
C0678222
patients with immediately life-threatening visceral disease for whom chemotherapy is preferred treatment option
Description

Disease Visceral Life Threatening | Chemotherapy Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C2826244
UMLS CUI [2]
C0392920
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.
Description

Chemotherapy Regimen Metastatic Neoplasm | Chemotherapy Regimen Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2939420
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0278488
subjects who received prior treatment or are already receiving everolimus treatment prior to study entry are not eligible
Description

Therapeutic procedure everolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0541315
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.
Description

Metastatic malignant neoplasm to brain | Leptomeningeal disease | Neurologic Symptoms | ct scan contrast Entire brain | Magnetic Resonance Imaging Entire brain | Central Nervous System Imaging Technology

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C3160796
UMLS CUI [3]
C0235031
UMLS CUI [4,1]
C0742919
UMLS CUI [4,2]
C1269537
UMLS CUI [5,1]
C0024485
UMLS CUI [5,2]
C1269537
UMLS CUI [6,1]
C3714787
UMLS CUI [6,2]
C1704382
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Similar models

Eligibility Breast Neoplasms NCT02258451

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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