ID

38058

Description

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation; ODM derived from: https://clinicaltrials.gov/show/NCT01572727

Link

https://clinicaltrials.gov/show/NCT01572727

Keywords

Versions (1)
  1. 9/12/19 9/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01572727

English

Eligibility Breast Cancer NCT01572727

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer that is locally advanced or metastatic
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 disease, and a known hormone receptor status (common breast cancer classification tests)
Description

Disease HER2 Negative | Hormone Receptor Status Known | Breast Carcinoma Classification Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348908
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0205309
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0008902
UMLS CUI [3,3]
C0392366
a tumor sample must be shipped to a central lab for identification of biomarkers (pi3k activation status) before randomization
Description

Tumor tissue sample | Biomarker Identification | PI3K Activation Status

Data type

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0205396
UMLS CUI [3,1]
C2936824
UMLS CUI [3,2]
C1879547
UMLS CUI [3,3]
C0449438
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
measurable or non-measurable disease
Description

Measurable Disease | Non-Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy for locally advanced or metastatic disease
Description

Prior Chemotherapy Advanced disease Locally | Prior Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0679246
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0027627
previous treatment with pi3k or akt inhibitors
Description

Prior Therapy | PI3K Inhibitor | AKT Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1519050
UMLS CUI [3,1]
C0812228
UMLS CUI [3,2]
C1999216
symptomatic brain metastases
Description

Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
concurrent malignancy or malignancy within 3 years prior to start of study treatment
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
certain drugs or radiation within 2-4 weeks of enrollment
Description

Pharmaceutical Preparations Specific Recently | Therapeutic radiology procedure Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Description

Adrenal Cortex Hormones Increased | Adrenal Cortex Hormones chronic | Immunosuppressive Agents Increased | Immunosuppressive Agents chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205217
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0021081
UMLS CUI [3,2]
C0205217
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
known hypersensitivity or contraindications to use paclitaxel
Description

Paclitaxel allergy | Medical contraindication Paclitaxel

Data type

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0144576
pregnant or nursing (lactating) woman
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
certain scores on an anxiety and depression mood questionaire given at screening
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 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 NCT01572727

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
breast cancer that is locally advanced or metastatic
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Disease HER2 Negative | Hormone Receptor Status Known | Breast Carcinoma Classification Test
Item
her2 negative disease, and a known hormone receptor status (common breast cancer classification tests)
boolean
C0012634 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0019929 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C0008902 (UMLS CUI [3,2])
C0392366 (UMLS CUI [3,3])
Tumor tissue sample | Biomarker Identification | PI3K Activation Status
Item
a tumor sample must be shipped to a central lab for identification of biomarkers (pi3k activation status) before randomization
boolean
C0475358 (UMLS CUI [1])
C0005516 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C2936824 (UMLS CUI [3,1])
C1879547 (UMLS CUI [3,2])
C0449438 (UMLS CUI [3,3])
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])
Measurable Disease | Non-Measurable Lesion
Item
measurable or non-measurable disease
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Advanced disease Locally | Prior Chemotherapy Neoplasm Metastasis
Item
prior chemotherapy for locally advanced or metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Prior Therapy | PI3K Inhibitor | AKT Inhibitor
Item
previous treatment with pi3k or akt inhibitors
boolean
C1514463 (UMLS CUI [1])
C1519050 (UMLS CUI [2])
C0812228 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Cancer Other
Item
concurrent malignancy or malignancy within 3 years prior to start of study treatment
boolean
C1707251 (UMLS CUI [1])
Pharmaceutical Preparations Specific Recently | Therapeutic radiology procedure Recently
Item
certain drugs or radiation within 2-4 weeks of enrollment
boolean
C0013227 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Adrenal Cortex Hormones Increased | Adrenal Cortex Hormones chronic | Immunosuppressive Agents Increased | Immunosuppressive Agents chronic
Item
increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
boolean
C0001617 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3,1])
C0205217 (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])
Paclitaxel allergy | Medical contraindication Paclitaxel
Item
known hypersensitivity or contraindications to use paclitaxel
boolean
C0570707 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Anxiety Questionnaire Score | Depressed mood Questionnaire Score
Item
certain scores on an anxiety and depression mood questionaire given at screening
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 criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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