ID

36385

Beschreibung

PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02423603

Link

https://clinicaltrials.gov/show/NCT02423603

Stichworte

Versionen (1)
  1. 09.05.19 09.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Mai 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT02423603

Englisch

Eligibility Metastatic Breast Cancer NCT02423603

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent prior to admission to this study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. women, age > 18 years
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. histologically confirmed breast cancer
Beschreibung

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
4. metastatic or locally recurrent disease; locally recurrent disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
Beschreibung

Neoplasm Metastasis | Locally Recurrent Malignant Neoplasm | Excision Curative intent Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C2986682
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C1272705
5. patient must have
Beschreibung

Patients Have

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with ct, or magnetic resonance imaging (mri) which is suitable for accurate repeated measurements, or
Beschreibung

Lesion Quantity | Prior radiation therapy Absent | Measurable lesion Longest Diameter CT | Measurable lesion Longest Diameter MRI | Exception Lymph nodes Short axis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0552406
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0552406
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0024204
UMLS CUI [5,3]
C0522488
lytic or mixed bone lesions in the absence of measurable disease as defined above; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.
Beschreibung

Lytic lesion | Bone lesion Mixed | Measurable Disease Absent | Bone lesion Sclerotic Ineligible | Bone lesion Osteoblast Ineligible

Datentyp

boolean

Alias
UMLS CUI [1]
C0221204
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C0205430
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0334135
UMLS CUI [4,3]
C1512714
UMLS CUI [5,1]
C0238792
UMLS CUI [5,2]
C0029418
UMLS CUI [5,3]
C1512714
6. radiological or clinical evidence of recurrence or progression
Beschreibung

Recurrent disease | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0242656
7. triple-negative disease, defined as tumour cells being
Beschreibung

Triple Negative Breast Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C3539878
negative for er with <1% of tumour cells positive for er on ihc or ihc score of
Beschreibung

Neoplastic Cell Estrogen receptor negative | Neoplastic Cell Estrogen receptor positive Percentage Immunohistochemistry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0279754
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0021044
negative for pr with <1% of tumour cells positive for pr on ihc or ihc score of
Beschreibung

Neoplastic Cell Progesterone receptor negative | Neoplastic Cell Progesterone receptor positive Percentage Immunohistochemistry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0279766
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0021044
≥2 or pr unknown
Beschreibung

Progesterone receptor status unknown

Datentyp

boolean

Alias
UMLS CUI [1]
C0279768
negative for her2 with 0, 1+ or 2+ intensity on ihc and no evidence of amplification on ish
Beschreibung

HER2 Negative Immunohistochemistry | HER2 gene amplification Absent In Situ Hybridization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0162788
8. formalin fixed paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing
Beschreibung

Availability Formalin-fixed paraffin-embedded tissue specimen Primary tumor | Availability Formalin-fixed paraffin-embedded tissue specimen Recurrent Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C2711483
UMLS CUI [1,3]
C0677930
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C2711483
UMLS CUI [2,3]
C0549379
9. patients must be able to swallow and retain oral medication
Beschreibung

Able to swallow Oral medication | Ability Retain Oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
10. haematologic and biochemical indices within protocol specified ranges
Beschreibung

Blood Indices Within reference range | Index Biochemical Within reference range

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4033634
UMLS CUI [1,2]
C0460094
UMLS CUI [2,1]
C0918012
UMLS CUI [2,2]
C0205474
UMLS CUI [2,3]
C0460094
11. ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
12. non-childbearing potential. if patient is of childbearing potential, she must have a negative serum pregnancy test and agree to use adequate contraception
Beschreibung

Childbearing Potential Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
13. willing and able to provide written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with confirm brain metastases or a history of primary central nervous system tumours or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
Beschreibung

Metastatic malignant neoplasm to brain | Central Nervous System Neoplasms, Primary | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0751620
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0220650
UMLS CUI [4,1]
C3897780
UMLS CUI [4,2]
C0332268
2. prior chemotherapy for metastatic breast cancer
Beschreibung

Prior Chemotherapy Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0346993
3. radiotherapy with a wide field of radiation within 4 weeks before the first dose of study medication
Beschreibung

Therapeutic radiology procedure Radiation Field Wide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C0332464
4. prior treatment with pi3k inhibitors, akt inhibitors or mtor inhibitors
Beschreibung

PI3K Inhibitor | AKT Inhibitor | mTOR Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2,1]
C0812228
UMLS CUI [2,2]
C1999216
UMLS CUI [3]
C2746052
5. prior treatment with paclitaxel or docetaxel in the (neo)adjuvant setting within 12 months from inclusion into this study
Beschreibung

Paclitaxel | docetaxel | Neoadjuvant Therapy | Adjuvant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2]
C0246415
UMLS CUI [3]
C0600558
UMLS CUI [4]
C0677850
6. pre-existing sensory or motor polyneuropathy ≥ grade 2 according to ctcae
Beschreibung

Sensory polyneuropathy Pre-existing CTCAE Grades | Motor Polyneuropathy Pre-existing CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0271681
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0271683
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C1516728
7. malabsorption syndrome or other condition that would interfere with enteral absorption
Beschreibung

Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C1304890
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1304890
8. clinically significant pulmonary dysfunction
Beschreibung

Pulmonary Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C1709770
9. prolongation defined as a qtc interval >470msecs or other significant abnormalities in rhythm, conduction or morphology of resting ecg including 2nd degree (type ii) or 3rd degree av block or bradycardia (ventricular rate <50 beats/min)
Beschreibung

Prolonged QTc interval | Rhythm Resting ECG Changes | Conduction Resting ECG Changes | Morphology Resting ECG Changes | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Ventricular Heart Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2,1]
C0871269
UMLS CUI [2,2]
C3897699
UMLS CUI [3,1]
C0232217
UMLS CUI [3,2]
C3897699
UMLS CUI [4,1]
C0332437
UMLS CUI [4,2]
C3897699
UMLS CUI [5]
C0264906
UMLS CUI [6]
C0151517
UMLS CUI [7]
C0428977
UMLS CUI [8]
C1883530
10. any factors that increase risk of qtc prolongation or risk of arrythmic events
Beschreibung

Factor At risk Prolonged QTc | Factor At risk Cardiac Arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1969409
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0003811
11. experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure nyha grade ≥2, or cardiac ejection fraction outside institutional range of normal or <50%
Beschreibung

Coronary Artery Bypass Surgery | Angioplasty | Vascular stent insertion | Myocardial Infarction | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Ejection fraction abnormal | Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0162577
UMLS CUI [3]
C1504337
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002962
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C1275491
UMLS CUI [7]
C0855327
UMLS CUI [8]
C0232174
12. clinically significant abnormalities of glucose metabolism
Beschreibung

Glucose metabolism abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C1142273
13. patients with proteinuria or creatine >1.5xuln concurrent with creatinine clearance <50ml/min
Beschreibung

Proteinuria | Creatinine increased | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2]
C0151578
UMLS CUI [3]
C0373595
14. exposure to potent inhibitors or inducers or substrates of cyp3a4 or substrates of cyp2d6 within 2 weeks before the first dose of study treatment
Beschreibung

Exposure to CYP3A4 Inhibitors Strong | Exposure to CYP3A4 Inducers Strong | Exposure to CYP3A4 Substrate Strong | Exposure to CYP2D6 Substrate Strong

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C3850053
UMLS CUI [1,3]
C0442821
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C3850041
UMLS CUI [2,3]
C0442821
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C3714798
UMLS CUI [3,3]
C3891814
UMLS CUI [3,4]
C0442821
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0057223
UMLS CUI [4,3]
C3891814
UMLS CUI [4,4]
C0442821
15. concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
Beschreibung

Study Subject Participation Status | Therapy, Investigational | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3]
C0013230
16. psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
Beschreibung

Psychological Factors Preventing Protocol Compliance | Factor Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033898
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
17. detained persons or prisoners
Beschreibung

Prisoners

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
18. pregnant or nursing women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Metastatic Breast Cancer NCT02423603

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent prior to admission to this study
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
2. women, age > 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
3. histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Neoplasm Metastasis | Locally Recurrent Malignant Neoplasm | Excision Curative intent Unsuccessful
Item
4. metastatic or locally recurrent disease; locally recurrent disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
boolean
C0027627 (UMLS CUI [1])
C2986682 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Patients Have
Item
5. patient must have
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
Lesion Quantity | Prior radiation therapy Absent | Measurable lesion Longest Diameter CT | Measurable lesion Longest Diameter MRI | Exception Lymph nodes Short axis
Item
at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with ct, or magnetic resonance imaging (mri) which is suitable for accurate repeated measurements, or
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0552406 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C0552406 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0024204 (UMLS CUI [5,2])
C0522488 (UMLS CUI [5,3])
Lytic lesion | Bone lesion Mixed | Measurable Disease Absent | Bone lesion Sclerotic Ineligible | Bone lesion Osteoblast Ineligible
Item
lytic or mixed bone lesions in the absence of measurable disease as defined above; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.
boolean
C0221204 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0334135 (UMLS CUI [4,2])
C1512714 (UMLS CUI [4,3])
C0238792 (UMLS CUI [5,1])
C0029418 (UMLS CUI [5,2])
C1512714 (UMLS CUI [5,3])
Recurrent disease | Disease Progression
Item
6. radiological or clinical evidence of recurrence or progression
boolean
C0277556 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Triple Negative Breast Neoplasms
Item
7. triple-negative disease, defined as tumour cells being
boolean
C3539878 (UMLS CUI [1])
Neoplastic Cell Estrogen receptor negative | Neoplastic Cell Estrogen receptor positive Percentage Immunohistochemistry
Item
negative for er with <1% of tumour cells positive for er on ihc or ihc score of
boolean
C0597032 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
Neoplastic Cell Progesterone receptor negative | Neoplastic Cell Progesterone receptor positive Percentage Immunohistochemistry
Item
negative for pr with <1% of tumour cells positive for pr on ihc or ihc score of
boolean
C0597032 (UMLS CUI [1,1])
C0279766 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
Progesterone receptor status unknown
Item
≥2 or pr unknown
boolean
C0279768 (UMLS CUI [1])
HER2 Negative Immunohistochemistry | HER2 gene amplification Absent In Situ Hybridization
Item
negative for her2 with 0, 1+ or 2+ intensity on ihc and no evidence of amplification on ish
boolean
C2348908 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0162788 (UMLS CUI [2,3])
Availability Formalin-fixed paraffin-embedded tissue specimen Primary tumor | Availability Formalin-fixed paraffin-embedded tissue specimen Recurrent Carcinoma
Item
8. formalin fixed paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing
boolean
C0470187 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C2711483 (UMLS CUI [2,2])
C0549379 (UMLS CUI [2,3])
Able to swallow Oral medication | Ability Retain Oral medication
Item
9. patients must be able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Blood Indices Within reference range | Index Biochemical Within reference range
Item
10. haematologic and biochemical indices within protocol specified ranges
boolean
C4033634 (UMLS CUI [1,1])
C0460094 (UMLS CUI [1,2])
C0918012 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C0460094 (UMLS CUI [2,3])
ECOG performance status
Item
11. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
12. non-childbearing potential. if patient is of childbearing potential, she must have a negative serum pregnancy test and agree to use adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
13. willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Central Nervous System Neoplasms, Primary | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Lacking
Item
1. patients with confirm brain metastases or a history of primary central nervous system tumours or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
boolean
C0220650 (UMLS CUI [1])
C0751620 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C3897780 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Prior Chemotherapy Secondary malignant neoplasm of female breast
Item
2. prior chemotherapy for metastatic breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Therapeutic radiology procedure Radiation Field Wide
Item
3. radiotherapy with a wide field of radiation within 4 weeks before the first dose of study medication
boolean
C1522449 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0332464 (UMLS CUI [1,3])
PI3K Inhibitor | AKT Inhibitor | mTOR Inhibitor
Item
4. prior treatment with pi3k inhibitors, akt inhibitors or mtor inhibitors
boolean
C1519050 (UMLS CUI [1])
C0812228 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C2746052 (UMLS CUI [3])
Paclitaxel | docetaxel | Neoadjuvant Therapy | Adjuvant therapy
Item
5. prior treatment with paclitaxel or docetaxel in the (neo)adjuvant setting within 12 months from inclusion into this study
boolean
C0144576 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
Sensory polyneuropathy Pre-existing CTCAE Grades | Motor Polyneuropathy Pre-existing CTCAE Grades
Item
6. pre-existing sensory or motor polyneuropathy ≥ grade 2 according to ctcae
boolean
C0271681 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0271683 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral
Item
7. malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C1304890 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Pulmonary Dysfunction
Item
8. clinically significant pulmonary dysfunction
boolean
C1709770 (UMLS CUI [1])
Prolonged QTc interval | Rhythm Resting ECG Changes | Conduction Resting ECG Changes | Morphology Resting ECG Changes | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Ventricular Heart Rate
Item
9. prolongation defined as a qtc interval >470msecs or other significant abnormalities in rhythm, conduction or morphology of resting ecg including 2nd degree (type ii) or 3rd degree av block or bradycardia (ventricular rate <50 beats/min)
boolean
C1560305 (UMLS CUI [1])
C0871269 (UMLS CUI [2,1])
C3897699 (UMLS CUI [2,2])
C0232217 (UMLS CUI [3,1])
C3897699 (UMLS CUI [3,2])
C0332437 (UMLS CUI [4,1])
C3897699 (UMLS CUI [4,2])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0428977 (UMLS CUI [7])
C1883530 (UMLS CUI [8])
Factor At risk Prolonged QTc | Factor At risk Cardiac Arrhythmia
Item
10. any factors that increase risk of qtc prolongation or risk of arrythmic events
boolean
C1521761 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1969409 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0003811 (UMLS CUI [2,3])
Coronary Artery Bypass Surgery | Angioplasty | Vascular stent insertion | Myocardial Infarction | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Ejection fraction abnormal | Cardiac ejection fraction
Item
11. experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure nyha grade ≥2, or cardiac ejection fraction outside institutional range of normal or <50%
boolean
C0010055 (UMLS CUI [1])
C0162577 (UMLS CUI [2])
C1504337 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0855327 (UMLS CUI [7])
C0232174 (UMLS CUI [8])
Glucose metabolism abnormal
Item
12. clinically significant abnormalities of glucose metabolism
boolean
C1142273 (UMLS CUI [1])
Proteinuria | Creatinine increased | Creatinine clearance measurement
Item
13. patients with proteinuria or creatine >1.5xuln concurrent with creatinine clearance <50ml/min
boolean
C0033687 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Exposure to CYP3A4 Inhibitors Strong | Exposure to CYP3A4 Inducers Strong | Exposure to CYP3A4 Substrate Strong | Exposure to CYP2D6 Substrate Strong
Item
14. exposure to potent inhibitors or inducers or substrates of cyp3a4 or substrates of cyp2d6 within 2 weeks before the first dose of study treatment
boolean
C0332157 (UMLS CUI [1,1])
C3850053 (UMLS CUI [1,2])
C0442821 (UMLS CUI [1,3])
C0332157 (UMLS CUI [2,1])
C3850041 (UMLS CUI [2,2])
C0442821 (UMLS CUI [2,3])
C0332157 (UMLS CUI [3,1])
C3714798 (UMLS CUI [3,2])
C3891814 (UMLS CUI [3,3])
C0442821 (UMLS CUI [3,4])
C0332157 (UMLS CUI [4,1])
C0057223 (UMLS CUI [4,2])
C3891814 (UMLS CUI [4,3])
C0442821 (UMLS CUI [4,4])
Study Subject Participation Status | Therapy, Investigational | Investigational New Drugs
Item
15. concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Psychological Factors Preventing Protocol Compliance | Factor Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance
Item
16. psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
boolean
C0033898 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Prisoners
Item
17. detained persons or prisoners
boolean
C0033167 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
18. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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