ID

35866

Description

Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01992952

Link

https://clinicaltrials.gov/show/NCT01992952

Keywords

Versions (1)
  1. 3/29/19 3/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Estrogen Receptor Positive Breast Cancer NCT01992952

English

Eligibility Estrogen Receptor Positive Breast Cancer NCT01992952

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
post-menopausal women
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
life expectancy 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
histological confirmation of er+ breast cancer
Description

Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C2938924
clinical or histological confirmation of metastatic or locally advanced disease not amenable to surgical resection
Description

Neoplasm Metastasis Inappropriate Excision | Advanced disease Locally Inappropriate Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C0679246
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C1548788
UMLS CUI [2,4]
C0728940
measurable or non-measurable disease
Description

Measurable Disease | Non-Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
adequate bone marrow, renal and hepatic function
Description

Bone Marrow function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
eastern cooperative oncology group (ecog) performance status < or equal to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
progressive disease whilst receiving an aromatase inhibitor (ai) for metastatic breast cancer (mbc)
Description

Progressive Disease | Aromatase Inhibitor Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0593802
UMLS CUI [2,2]
C0346993
relapsed with metastatic disease whilst receiving an ai in adjuvant setting
Description

Metastatic/Recurrent Disease | Aromatase Inhibitor Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C1334739
UMLS CUI [2,1]
C0593802
UMLS CUI [2,2]
C0677850
up to 3 prior lines endocrine therapy for mbc
Description

Hormone Therapy Quantity Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
up to 1 line of chemotherapy in the metastatic setting
Description

Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
patient willing to donate archival tumour sample
Description

Tumor tissue sample Donation

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0680854
patient willing to donate baseline blood sample
Description

Blood specimen Donation

Data type

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0680854
adequate bone marrow and organ function
Description

Bone Marrow function | Organ function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
suitable for further endocrine therapy
Description

Suitable Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3900053
UMLS CUI [1,2]
C0279025
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with fulvestrant or pi3k/mtor(mammalian target of rapamycin )/akt inhibitor therapy
Description

fulvestrant | Phosphatidylinositide 3-Kinase Inhibitor | mTOR Inhibitor | AKT1 gene Inhibitor | AKT2 gene Inhibitor | AKT3 gene Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0935916
UMLS CUI [2]
C1519050
UMLS CUI [3]
C2746052
UMLS CUI [4,1]
C0812228
UMLS CUI [4,2]
C1999216
UMLS CUI [5,1]
C0812230
UMLS CUI [5,2]
C1999216
UMLS CUI [6,1]
C1332074
UMLS CUI [6,2]
C1999216
clinically significant abnormalities in glucose metabolism
Description

Glucose metabolism abnormal

Data type

boolean

Alias
UMLS CUI [1]
C1142273
rapidly progressive visceral disease not suitable for further endocrine therapy
Description

Disease Visceral Rapidly progressive | Hormone Therapy Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C1838681
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1548788
known brain or leptomeningeal metastases
Description

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
any co-existing medical condition precluding trial entry including significant cardiac disease (to be defined in the protocol)
Description

Comorbidity Study Subject Participation Status Excluded | Heart Disease Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0750502
concomitant medication unsuitable for combination with trial medication
Description

Pharmaceutical Preparations Inappropriate Combination Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0205195
UMLS CUI [1,4]
C0013230
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Similar models

Eligibility Estrogen Receptor Positive Breast Cancer NCT01992952

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
post-menopausal women
boolean
C0232970 (UMLS CUI [1])
Life Expectancy
Item
life expectancy 3 months
boolean
C0023671 (UMLS CUI [1])
Oestrogen receptor positive breast cancer
Item
histological confirmation of er+ breast cancer
boolean
C2938924 (UMLS CUI [1])
Neoplasm Metastasis Inappropriate Excision | Advanced disease Locally Inappropriate Excision
Item
clinical or histological confirmation of metastatic or locally advanced disease not amenable to surgical resection
boolean
C0027627 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0679246 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0728940 (UMLS CUI [2,4])
Measurable Disease | Non-Measurable Lesion
Item
measurable or non-measurable disease
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal and hepatic function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status < or equal to 2
boolean
C1520224 (UMLS CUI [1])
Progressive Disease | Aromatase Inhibitor Secondary malignant neoplasm of female breast
Item
progressive disease whilst receiving an aromatase inhibitor (ai) for metastatic breast cancer (mbc)
boolean
C1335499 (UMLS CUI [1])
C0593802 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Metastatic/Recurrent Disease | Aromatase Inhibitor Adjuvant therapy
Item
relapsed with metastatic disease whilst receiving an ai in adjuvant setting
boolean
C1334739 (UMLS CUI [1])
C0593802 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
Hormone Therapy Quantity Secondary malignant neoplasm of female breast
Item
up to 3 prior lines endocrine therapy for mbc
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Chemotherapy Quantity Neoplasm Metastasis
Item
up to 1 line of chemotherapy in the metastatic setting
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Tumor tissue sample Donation
Item
patient willing to donate archival tumour sample
boolean
C0475358 (UMLS CUI [1,1])
C0680854 (UMLS CUI [1,2])
Blood specimen Donation
Item
patient willing to donate baseline blood sample
boolean
C0178913 (UMLS CUI [1,1])
C0680854 (UMLS CUI [1,2])
Bone Marrow function | Organ function
Item
adequate bone marrow and organ function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Suitable Hormone Therapy
Item
suitable for further endocrine therapy
boolean
C3900053 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
fulvestrant | Phosphatidylinositide 3-Kinase Inhibitor | mTOR Inhibitor | AKT1 gene Inhibitor | AKT2 gene Inhibitor | AKT3 gene Inhibitor
Item
previous treatment with fulvestrant or pi3k/mtor(mammalian target of rapamycin )/akt inhibitor therapy
boolean
C0935916 (UMLS CUI [1])
C1519050 (UMLS CUI [2])
C2746052 (UMLS CUI [3])
C0812228 (UMLS CUI [4,1])
C1999216 (UMLS CUI [4,2])
C0812230 (UMLS CUI [5,1])
C1999216 (UMLS CUI [5,2])
C1332074 (UMLS CUI [6,1])
C1999216 (UMLS CUI [6,2])
Glucose metabolism abnormal
Item
clinically significant abnormalities in glucose metabolism
boolean
C1142273 (UMLS CUI [1])
Disease Visceral Rapidly progressive | Hormone Therapy Inappropriate
Item
rapidly progressive visceral disease not suitable for further endocrine therapy
boolean
C0012634 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C1838681 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
known brain or leptomeningeal metastases
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Comorbidity Study Subject Participation Status Excluded | Heart Disease Significant
Item
any co-existing medical condition precluding trial entry including significant cardiac disease (to be defined in the protocol)
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Pharmaceutical Preparations Inappropriate Combination Investigational New Drugs
Item
concomitant medication unsuitable for combination with trial medication
boolean
C0013227 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
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