ID

39895

Beskrivning

Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01446159

Länk

https://clinicaltrials.gov/show/NCT01446159

Nyckelord

Versioner (1)
  1. 2020-03-01 2020-03-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 mars 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer NCT01446159

Engelsk

Eligibility Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer NCT01446159

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically-confirmed mbc not deemed amenable to curative surgery or curative radiation therapy
Beskrivning

Secondary malignant neoplasm of female breast Inappropriate Curative Surgery | Secondary malignant neoplasm of female breast Inappropriate Therapeutic radiology procedure Curative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1511562
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1522449
UMLS CUI [2,4]
C1276305
tumors are positive for er, pgr, or both
Beskrivning

Tumor Estrogen receptor positive | Progesterone receptor positive tumor | Tumor Estrogen receptor positive Progesterone receptor positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279754
UMLS CUI [2]
C1562928
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0279754
UMLS CUI [3,3]
C0279759
tumors must be negative for her2 (by fish, cish or ihc)
Beskrivning

Tumor HER2 Negative FISH | Tumor HER2 Negative CISH | Tumor HER2 Negative Immunohistochemistry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348908
UMLS CUI [1,3]
C0162789
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2348908
UMLS CUI [2,3]
C1516514
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C2348908
UMLS CUI [3,3]
C0021044
female gender and age ≥ 18 years at time of study entry
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
postmenopausal
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
karnofsky performance status ≥ 70
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of ≥ 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:
Beskrivning

Prior Chemotherapy Advanced disease | Prior Hormone Therapy Advanced disease | Prior Immunotherapy Advanced disease | Biological treatment Advanced disease | Prior Chemotherapy Neoplasm Metastasis | Prior Hormone Therapy Neoplasm Metastasis | Prior Immunotherapy Neoplasm Metastasis | Biological treatment Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0679246
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0679246
UMLS CUI [3,1]
C1514461
UMLS CUI [3,2]
C0679246
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0679246
UMLS CUI [5,1]
C1514457
UMLS CUI [5,2]
C0027627
UMLS CUI [6,1]
C1514460
UMLS CUI [6,2]
C0027627
UMLS CUI [7,1]
C1514461
UMLS CUI [7,2]
C0027627
UMLS CUI [8,1]
C1531518
UMLS CUI [8,2]
C0027627
prior adjuvant therapy with an ai and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of medi-573
Beskrivning

Exception | Prior Adjuvant Therapy | Aromatase Inhibitors | Tamoxifen | Treatment completed

Datatyp

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2]
C1514456
UMLS CUI [3]
C0593802
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0580352
prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
Beskrivning

Exception | Neoadjuvant Chemotherapy Previous Breast Carcinoma | Prior adjuvant chemotherapy Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C0205156
UMLS CUI [2,4]
C0678222
UMLS CUI [3,1]
C0281265
UMLS CUI [3,2]
C0678222
extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)
Beskrivning

Disease Visceral Symptomatic Extensive | Hepatic Involvement | Lymphangitic spread pulmonary Tumor | Disease Rapidly progressive | Life threatening illness | Study Subject intended Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C0231220
UMLS CUI [1,4]
C0205231
UMLS CUI [2]
C0441932
UMLS CUI [3,1]
C3697833
UMLS CUI [3,2]
C0024109
UMLS CUI [3,3]
C0027651
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1838681
UMLS CUI [5]
C3846017
UMLS CUI [6,1]
C0681850
UMLS CUI [6,2]
C1283828
UMLS CUI [6,3]
C0392920
active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of cns progression for at least 4 weeks of first dose of medi-573
Beskrivning

Metastatic malignant neoplasm to brain | Exception Study Subject Treated Asymptomatic | Exception CNS Progression Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0681850
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0231221
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3714787
UMLS CUI [3,3]
C0242656
UMLS CUI [3,4]
C0332197
evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
Beskrivning

Compression of spinal cord | Meningeal Carcinomatosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0220654
unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ grade 1 at the time of starting study treatment
Beskrivning

Toxicity Due to Prior Therapy | Resolution Lacking | Exception Alopecia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
previous treatment with agents that target the igf receptor
Beskrivning

Pharmaceutical Preparations Targeting IGF Receptor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0140079
history of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of medi-573 or ai
Beskrivning

Hypersensitivity Compound MEDI-573 Similar | Hypersensitivity Compound Aromatase Inhibitors Similar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C2830209
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0593802
UMLS CUI [2,4]
C2348205
history of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix
Beskrivning

Cancer Other Invasive | Exception Skin carcinoma Curative Resected | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1276305
UMLS CUI [2,4]
C1521996
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
poorly controlled diabetes mellitus
Beskrivning

Poorly controlled diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0554876
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Similar models

Eligibility Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer NCT01446159

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast Inappropriate Curative Surgery | Secondary malignant neoplasm of female breast Inappropriate Therapeutic radiology procedure Curative
Item
histologically-confirmed mbc not deemed amenable to curative surgery or curative radiation therapy
boolean
C0346993 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1511562 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
Tumor Estrogen receptor positive | Progesterone receptor positive tumor | Tumor Estrogen receptor positive Progesterone receptor positive
Item
tumors are positive for er, pgr, or both
boolean
C0027651 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C1562928 (UMLS CUI [2])
C0027651 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C0279759 (UMLS CUI [3,3])
Tumor HER2 Negative FISH | Tumor HER2 Negative CISH | Tumor HER2 Negative Immunohistochemistry
Item
tumors must be negative for her2 (by fish, cish or ihc)
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C1516514 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C2348908 (UMLS CUI [3,2])
C0021044 (UMLS CUI [3,3])
Gender | Age
Item
female gender and age ≥ 18 years at time of study entry
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status ≥ 70
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Advanced disease | Prior Hormone Therapy Advanced disease | Prior Immunotherapy Advanced disease | Biological treatment Advanced disease | Prior Chemotherapy Neoplasm Metastasis | Prior Hormone Therapy Neoplasm Metastasis | Prior Immunotherapy Neoplasm Metastasis | Biological treatment Neoplasm Metastasis
Item
subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:
boolean
C1514457 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C1514461 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C0679246 (UMLS CUI [4,2])
C1514457 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C1514460 (UMLS CUI [6,1])
C0027627 (UMLS CUI [6,2])
C1514461 (UMLS CUI [7,1])
C0027627 (UMLS CUI [7,2])
C1531518 (UMLS CUI [8,1])
C0027627 (UMLS CUI [8,2])
Exception | Prior Adjuvant Therapy | Aromatase Inhibitors | Tamoxifen | Treatment completed
Item
prior adjuvant therapy with an ai and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of medi-573
boolean
C1705847 (UMLS CUI [1])
C1514456 (UMLS CUI [2])
C0593802 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
C0580352 (UMLS CUI [5])
Exception | Neoadjuvant Chemotherapy Previous Breast Carcinoma | Prior adjuvant chemotherapy Breast Carcinoma
Item
prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
boolean
C1705847 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0678222 (UMLS CUI [2,4])
C0281265 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Disease Visceral Symptomatic Extensive | Hepatic Involvement | Lymphangitic spread pulmonary Tumor | Disease Rapidly progressive | Life threatening illness | Study Subject intended Chemotherapy
Item
extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)
boolean
C0012634 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0205231 (UMLS CUI [1,4])
C0441932 (UMLS CUI [2])
C3697833 (UMLS CUI [3,1])
C0024109 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1838681 (UMLS CUI [4,2])
C3846017 (UMLS CUI [5])
C0681850 (UMLS CUI [6,1])
C1283828 (UMLS CUI [6,2])
C0392920 (UMLS CUI [6,3])
Metastatic malignant neoplasm to brain | Exception Study Subject Treated Asymptomatic | Exception CNS Progression Absent
Item
active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of cns progression for at least 4 weeks of first dose of medi-573
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0681850 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0231221 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3714787 (UMLS CUI [3,2])
C0242656 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Compression of spinal cord | Meningeal Carcinomatosis
Item
evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
boolean
C0037926 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Toxicity Due to Prior Therapy | Resolution Lacking | Exception Alopecia
Item
unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ grade 1 at the time of starting study treatment
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
Pharmaceutical Preparations Targeting IGF Receptor
Item
previous treatment with agents that target the igf receptor
boolean
C0013227 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0140079 (UMLS CUI [1,3])
Hypersensitivity Compound MEDI-573 Similar | Hypersensitivity Compound Aromatase Inhibitors Similar
Item
history of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of medi-573 or ai
boolean
C0020517 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C2830209 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0593802 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Cancer Other Invasive | Exception Skin carcinoma Curative Resected | Exception Carcinoma in situ of uterine cervix
Item
history of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1276305 (UMLS CUI [2,3])
C1521996 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes mellitus
boolean
C0554876 (UMLS CUI [1])
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