ID

35023

Description

Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02404844

Link

https://clinicaltrials.gov/show/NCT02404844

Keywords

Versions (1)
  1. 2/10/19 2/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02404844

English

Eligibility Breast Cancer NCT02404844

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has histologically and/or cytologically confirmed diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
patient has radiologic or objective evidence of inoperable locally advanced, or metastatic breast cancer
Description

Locally advanced breast cancer Inoperable | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0205187
UMLS CUI [2]
C0346993
patient has a known hormone receptor status hr-positive (er and/or pr positive) and her2-negative status
Description

Hormone Receptor Positive | Estrogen receptor positive | Progesterone receptor positive | HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
UMLS CUI [4]
C2348908
patient has a representative archival formalin-fixed tumor biopsy (metastasis or primary tumor)
Description

Availability of Tumor tissue sample | Neoplasm Metastasis | Primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0027627
UMLS CUI [3]
C0677930
patient has prior exposure to antihormonal therapy
Description

Exposure to Antihormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2986607
patient has received ≤ 2 prior antihormonal treatments in the metastatic setting
Description

Antihormone Therapy Quantity | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C2986607
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0027627
prior treatment with tamoxifen in the (neo-)adjuvant setting is allowed but has to be discontinued for at least 1 year.
Description

Tamoxifen To be stopped | Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C1272691
UMLS CUI [2]
C0600558
patient may have received up to one prior chemotherapy in the metastatic setting
Description

Prior Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
measurable or non-measurable lesions according to recist v1.1 criteria
Description

Measurable lesion | Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0221198
patient has an eastern cooperative oncology group (ecog) performance status score ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has received previous treatment with a pi3k- or akt-inhibitor or mtor-inhibitors
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2,1]
C0812228
UMLS CUI [2,2]
C1999216
UMLS CUI [3,1]
C0812230
UMLS CUI [3,2]
C1999216
UMLS CUI [4,1]
C1332074
UMLS CUI [4,2]
C1999216
UMLS CUI [5]
C2746052
prior treatment with tamoxifen in the metastatic setting. treatment with tamoxifen in the (neo-)adjuvant setting is allowed, but has to be discontinued for at least 1 year
Description

Tamoxifen | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0027627
patient has symptomatic cns metastases
Description

CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
patient has a medically documented history of or active major depressive episode, bipolar disorder (i or ii), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to dsm-iv).
Description

Major depressive episode | Bipolar I disorder | Bipolar II disorder | Obsessive-Compulsive Disorder | Schizophrenia | Suicide attempt | Feeling suicidal | Homicidal thoughts | At risk for deliberate self harm | Risk of violence or harm to others | Personality Disorders Severe

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0853193
UMLS CUI [3]
C0236788
UMLS CUI [4]
C0028768
UMLS CUI [5]
C0036341
UMLS CUI [6]
C0038663
UMLS CUI [7]
C0424000
UMLS CUI [8]
C0455204
UMLS CUI [9]
C1276053
UMLS CUI [10]
C0549013
UMLS CUI [11,1]
C0031212
UMLS CUI [11,2]
C0205082
patient has a known history of hiv infection (testing not mandatory) infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Breast Cancer NCT02404844

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
patient has histologically and/or cytologically confirmed diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Locally advanced breast cancer Inoperable | Secondary malignant neoplasm of female breast
Item
patient has radiologic or objective evidence of inoperable locally advanced, or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
Hormone Receptor Positive | Estrogen receptor positive | Progesterone receptor positive | HER2 Negative
Item
patient has a known hormone receptor status hr-positive (er and/or pr positive) and her2-negative status
boolean
C0019929 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C2348908 (UMLS CUI [4])
Availability of Tumor tissue sample | Neoplasm Metastasis | Primary tumor
Item
patient has a representative archival formalin-fixed tumor biopsy (metastasis or primary tumor)
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0677930 (UMLS CUI [3])
Exposure to Antihormone Therapy
Item
patient has prior exposure to antihormonal therapy
boolean
C0332157 (UMLS CUI [1,1])
C2986607 (UMLS CUI [1,2])
Antihormone Therapy Quantity | Neoplasm Metastasis
Item
patient has received ≤ 2 prior antihormonal treatments in the metastatic setting
boolean
C2986607 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
Tamoxifen To be stopped | Neoadjuvant Therapy
Item
prior treatment with tamoxifen in the (neo-)adjuvant setting is allowed but has to be discontinued for at least 1 year.
boolean
C0039286 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2])
Prior Chemotherapy Neoplasm Metastasis
Item
patient may have received up to one prior chemotherapy in the metastatic setting
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Measurable lesion | Lesion
Item
measurable or non-measurable lesions according to recist v1.1 criteria
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
ECOG performance status
Item
patient has an eastern cooperative oncology group (ecog) performance status score ≤ 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Phosphatidylinositide 3-Kinase Inhibitor | AKT1 gene Inhibitor | AKT2 gene Inhibitor | AKT3 gene Inhibitor | mTOR Inhibitor
Item
patient has received previous treatment with a pi3k- or akt-inhibitor or mtor-inhibitors
boolean
C1519050 (UMLS CUI [1])
C0812228 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C0812230 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
C1332074 (UMLS CUI [4,1])
C1999216 (UMLS CUI [4,2])
C2746052 (UMLS CUI [5])
Tamoxifen | Neoplasm Metastasis
Item
prior treatment with tamoxifen in the metastatic setting. treatment with tamoxifen in the (neo-)adjuvant setting is allowed, but has to be discontinued for at least 1 year
boolean
C0039286 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
CNS metastases Symptomatic
Item
patient has symptomatic cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Major depressive episode | Bipolar I disorder | Bipolar II disorder | Obsessive-Compulsive Disorder | Schizophrenia | Suicide attempt | Feeling suicidal | Homicidal thoughts | At risk for deliberate self harm | Risk of violence or harm to others | Personality Disorders Severe
Item
patient has a medically documented history of or active major depressive episode, bipolar disorder (i or ii), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to dsm-iv).
boolean
C0024517 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
C0236788 (UMLS CUI [3])
C0028768 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0038663 (UMLS CUI [6])
C0424000 (UMLS CUI [7])
C0455204 (UMLS CUI [8])
C1276053 (UMLS CUI [9])
C0549013 (UMLS CUI [10])
C0031212 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
HIV Infection
Item
patient has a known history of hiv infection (testing not mandatory) infection
boolean
C0019693 (UMLS CUI [1])
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