ID

38065

Description

Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor; ODM derived from: https://clinicaltrials.gov/show/NCT01610284

Link

https://clinicaltrials.gov/show/NCT01610284

Keywords

Versions (1)
  1. 9/14/19 9/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01610284

English

Eligibility Breast Cancer NCT01610284

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic breast cancer
Description

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
her2-negative and hormone receptor-positive status (common breast cancer classification tests)
Description

HER2 Negative | Hormone Receptor Positive | Breast Carcinoma Classification Tests

Data type

boolean

Alias
UMLS CUI [1]
C2348908
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0008902
UMLS CUI [3,3]
C0392366
postmenopausal woman
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
a tumor sample must be shipped to a novartis designated laboratory for identification of biomarkers (pi3k activation status)
Description

Availability of Tumor tissue sample | Biomarker Identification | PI-3K Activation

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0205396
UMLS CUI [3,1]
C2936824
UMLS CUI [3,2]
C1879547
progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
Description

Progression Breast Carcinoma | Breast cancer recurrent | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0449258
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0278493
UMLS CUI [3]
C0593802
measurable disease or non measurable disease bone lesions in the absence of measurable disease as per recist 1.1
Description

Measurable Disease | Non-Measurable Lesion | Bone lesion Measurable Disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
UMLS CUI [3,1]
C0238792
UMLS CUI [3,2]
C1513041
UMLS CUI [3,3]
C0332197
adequate bone marrow and organ function defined by laboratory values
Description

Bone Marrow function Definition Laboratory Results | Organ function Definition Laboratory Results

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C1704788
UMLS CUI [1,4]
C1254595
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C1704788
UMLS CUI [2,3]
C1254595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with pi3k inhibitors, akt inhibitors, mtor inhibitor or fulvestrant
Description

Prior Therapy | PI3K Inhibitor | AKT inhibitors | mTOR Inhibitors | fulvestrant

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1519050
UMLS CUI [3,1]
C0812228
UMLS CUI [3,2]
C0243077
UMLS CUI [4]
C1515672
UMLS CUI [5]
C0935916
more than one prior chemotherapy line for metastatic disease
Description

Prior Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
symptomatic brain metastases
Description

Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Description

Adrenal Cortex Hormones Increasing | Adrenal Cortex Hormones chronic | Immunosuppressive Agents Increasing | Immunosuppressive Agents chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0442808
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0021081
UMLS CUI [3,2]
C0442808
UMLS CUI [4,1]
C0021081
UMLS CUI [4,2]
C0205191
active heart (cardiac) disease as defined in the protocol
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
certain scores on an anxiety and depression mood questionnaires
Description

Anxiety Questionnaire Score | Depressed mood Questionnaire Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0003467
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0449820
UMLS CUI [2,1]
C0344315
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0449820
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT01610284

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
HER2 Negative | Hormone Receptor Positive | Breast Carcinoma Classification Tests
Item
her2-negative and hormone receptor-positive status (common breast cancer classification tests)
boolean
C2348908 (UMLS CUI [1])
C0019929 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0678222 (UMLS CUI [3,1])
C0008902 (UMLS CUI [3,2])
C0392366 (UMLS CUI [3,3])
Postmenopausal state
Item
postmenopausal woman
boolean
C0232970 (UMLS CUI [1])
Availability of Tumor tissue sample | Biomarker Identification | PI-3K Activation
Item
a tumor sample must be shipped to a novartis designated laboratory for identification of biomarkers (pi3k activation status)
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0005516 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C2936824 (UMLS CUI [3,1])
C1879547 (UMLS CUI [3,2])
Progression Breast Carcinoma | Breast cancer recurrent | Aromatase Inhibitors
Item
progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
boolean
C0449258 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2])
C0593802 (UMLS CUI [3])
Measurable Disease | Non-Measurable Lesion | Bone lesion Measurable Disease Absent
Item
measurable disease or non measurable disease bone lesions in the absence of measurable disease as per recist 1.1
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
C0238792 (UMLS CUI [3,1])
C1513041 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Bone Marrow function Definition Laboratory Results | Organ function Definition Laboratory Results
Item
adequate bone marrow and organ function defined by laboratory values
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
C1254595 (UMLS CUI [1,4])
C0678852 (UMLS CUI [2,1])
C1704788 (UMLS CUI [2,2])
C1254595 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | PI3K Inhibitor | AKT inhibitors | mTOR Inhibitors | fulvestrant
Item
previous treatment with pi3k inhibitors, akt inhibitors, mtor inhibitor or fulvestrant
boolean
C1514463 (UMLS CUI [1])
C1519050 (UMLS CUI [2])
C0812228 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
C1515672 (UMLS CUI [4])
C0935916 (UMLS CUI [5])
Prior Chemotherapy Quantity Neoplasm Metastasis
Item
more than one prior chemotherapy line for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Adrenal Cortex Hormones Increasing | Adrenal Cortex Hormones chronic | Immunosuppressive Agents Increasing | Immunosuppressive Agents chronic
Item
increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
boolean
C0001617 (UMLS CUI [1,1])
C0442808 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3,1])
C0442808 (UMLS CUI [3,2])
C0021081 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Heart Disease
Item
active heart (cardiac) disease as defined in the protocol
boolean
C0018799 (UMLS CUI [1])
Anxiety Questionnaire Score | Depressed mood Questionnaire Score
Item
certain scores on an anxiety and depression mood questionnaires
boolean
C0003467 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0344315 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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