ID

43810

Description

Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy 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/NCT02258464

Link

https://clinicaltrials.gov/show/NCT02258464

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 NCT02258464

English

Eligibility Breast Neoplasms NCT02258464

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0278488
UMLS CUI [4]
C1273390
UMLS CUI [5]
C0543467
UMLS CUI [6]
C1522449
documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
Description

Menopausal Status | Postmenopausal state | Premenopausal

Data type

boolean

Alias
UMLS CUI [1]
C3829127
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0279752
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).
Description

Bone Diseases | Neoplasm Metastasis Soft tissue Lymph nodes | Neoplasm Metastasis Skeletal | Bone scintigraphy X-Ray Computed Tomography Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0005940
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0225317
UMLS CUI [2,3]
C0024204
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0521324
UMLS CUI [4,1]
C3889015
UMLS CUI [4,2]
C0040405
UMLS CUI [4,3]
C0024485
measurable or non-measurable disease (but radiologically evaluable) according to response evaluation criteria in solid tumors (recist) v1.1 criteria.
Description

Measurable Disease | Non-Measurable Tumor Identification | Evaluation procedure Radiologic | Response Evaluation Criteria in Solid Tumors

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C3538912
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C0205483
UMLS CUI [4]
C1709926
subjects must have received at least one line of hormonal therapy in the metastatic setting
Description

Hormone Therapy Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2939420
subjects who are eligible for further standard of care endocrine treatment.
Description

Standard of Care Therapeutic procedure Endocrine system

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0014136
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.
Description

Hormone preparation Singular | RADIUM CHLORIDE RA-223

Data type

boolean

Alias
UMLS CUI [1,1]
C0019932
UMLS CUI [1,2]
C0205171
UMLS CUI [2]
C3541342
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 bisphosphonate and denosumab. and are required to have been on such therapy for at least 3 months 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 Symptomatic Mild

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0231221
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C2945599
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 Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2,1]
C0205448
UMLS CUI [2,2]
C0006826
history and/or presence of confirmed visceral metastases.
Description

Neoplasm Metastasis Visceral

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
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 Neoplasm Metastasis | Chemotherapy Regimen Carcinoma breast stage IV | Adjuvant therapy | Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0278488
UMLS CUI [3]
C0677850
UMLS CUI [4]
C0600558
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 Techniques

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]
C0079595
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Similar models

Eligibility Breast Neoplasms NCT02258464

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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
C3829127 (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
C0019932 (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])
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 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])
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