ID

40878

Descrição

NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01816594

Link

https://clinicaltrials.gov/show/NCT01816594

Palavras-chave

Versões (1)
  1. 29/05/2020 29/05/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de maio de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility HER2-positive, Newly Diagnosed, Primary Breast Cancer, Neoadjuvant Therapy, Trastuzumab NCT01816594

Inglês

Eligibility HER2-positive, Newly Diagnosed, Primary Breast Cancer, Neoadjuvant Therapy, Trastuzumab NCT01816594

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is a female ≥ 18 years of age
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patient has an ecog performance status of 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by mri
Descrição

Early-Stage Breast Carcinoma Unilateral | Tumor size Clinical examination | Tumor size Ultrasonography | Tumor size MRI | Disease Multifocal allowed | Disease Multicentric allowed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2986665
UMLS CUI [1,2]
C0205092
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C1456356
UMLS CUI [3,1]
C0475440
UMLS CUI [3,2]
C0041618
UMLS CUI [4,1]
C0475440
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205292
UMLS CUI [5,3]
C0683607
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0439743
UMLS CUI [6,3]
C0683607
patient has tumor tissue available for central review of er, her2 and pi3k status with centrally confirmed her2-positive disease and known pi3kca mutation status
Descrição

Tumor tissue sample ER Status | Tumor tissue sample HER2 Status | Tumor tissue sample PI3K Status | Disease HER2 Positive | PIK3CA Gene Mutation Status Known

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1516974
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C1512413
UMLS CUI [3,1]
C0475358
UMLS CUI [3,2]
C2936824
UMLS CUI [3,3]
C0449438
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C2348909
UMLS CUI [5,1]
C3272694
UMLS CUI [5,2]
C0449438
UMLS CUI [5,3]
C0205309
patient has adequate bone marrow, renal and liver function
Descrição

Bone Marrow function | Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
patient is able to swallow and retain oral medication
Descrição

Able to swallow Oral medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has received prior systemic treatment for currently diagnosed disease
Descrição

Systemic therapy Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205156
patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor
Descrição

Medical contraindication Trastuzumab | Hypersensitivity Trastuzumab | Intolerance to Trastuzumab | Medical contraindication Paclitaxel | Hypersensitivity Paclitaxel | Intolerance to Paclitaxel | Medical contraindication Cremophor Product | Hypersensitivity Cremophor Product | Intolerance to Cremophor Product

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0728747
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0728747
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0144576
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0144576
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0144576
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0056475
UMLS CUI [7,3]
C1254351
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0056475
UMLS CUI [8,3]
C1254351
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C0056475
UMLS CUI [9,3]
C1254351
patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer
Descrição

Bilateral breast cancer | Neoplasm Metastasis | Inflammatory Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C0027627
UMLS CUI [3]
C0278601
lvef below 50% as determined by muga scan or echo
Descrição

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol
Descrição

Heart Disease | Cardiac abnormalities

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018798
patient has impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bkm120
Descrição

Gastrointestinal function Impaired | Gastrointestinal Disease Changing Absorption BKM120

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0516983
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C3491291
patient is currently receiving warfarin or other coumarin derived anti-coagulants
Descrição

Warfarin | Coumarin Derivative Anticoagulants

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C0010206
UMLS CUI [2,2]
C1527240
UMLS CUI [2,3]
C0003280
patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)
Descrição

Adrenal Cortex Hormones chronic | Immunosuppressive Agents chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of cyp3a
Descrição

CYP3A Inhibitors Strong | CYP3A Inducers Strong

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850044
UMLS CUI [2,2]
C0442821
patient has certain scores on an anxiety and depression mood questionnaires
Descrição

Score Anxiety Depressed mood Questionnaires

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C0003467
UMLS CUI [1,3]
C0344315
UMLS CUI [1,4]
C0034394
pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol
Descrição

Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling | Patients Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
other protocol defined criteria may apply
Descrição

Eligibility Criteria Study Protocol

Tipo de dados

boolean

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

Eligibility HER2-positive, Newly Diagnosed, Primary Breast Cancer, Neoadjuvant Therapy, Trastuzumab NCT01816594

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
patient is a female ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
patient has an ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Early-Stage Breast Carcinoma Unilateral | Tumor size Clinical examination | Tumor size Ultrasonography | Tumor size MRI | Disease Multifocal allowed | Disease Multicentric allowed
Item
patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by mri
boolean
C2986665 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
C0475440 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0205292 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0439743 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Tumor tissue sample ER Status | Tumor tissue sample HER2 Status | Tumor tissue sample PI3K Status | Disease HER2 Positive | PIK3CA Gene Mutation Status Known
Item
patient has tumor tissue available for central review of er, her2 and pi3k status with centrally confirmed her2-positive disease and known pi3kca mutation status
boolean
C0475358 (UMLS CUI [1,1])
C1516974 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C1512413 (UMLS CUI [2,2])
C0475358 (UMLS CUI [3,1])
C2936824 (UMLS CUI [3,2])
C0449438 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C2348909 (UMLS CUI [4,2])
C3272694 (UMLS CUI [5,1])
C0449438 (UMLS CUI [5,2])
C0205309 (UMLS CUI [5,3])
Bone Marrow function | Renal function | Liver function
Item
patient has adequate bone marrow, renal and liver function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Able to swallow Oral medication
Item
patient is able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Previous
Item
patient has received prior systemic treatment for currently diagnosed disease
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Medical contraindication Trastuzumab | Hypersensitivity Trastuzumab | Intolerance to Trastuzumab | Medical contraindication Paclitaxel | Hypersensitivity Paclitaxel | Intolerance to Paclitaxel | Medical contraindication Cremophor Product | Hypersensitivity Cremophor Product | Intolerance to Cremophor Product
Item
patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor
boolean
C1301624 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0144576 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0144576 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0144576 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0056475 (UMLS CUI [7,2])
C1254351 (UMLS CUI [7,3])
C0020517 (UMLS CUI [8,1])
C0056475 (UMLS CUI [8,2])
C1254351 (UMLS CUI [8,3])
C1744706 (UMLS CUI [9,1])
C0056475 (UMLS CUI [9,2])
C1254351 (UMLS CUI [9,3])
Bilateral breast cancer | Neoplasm Metastasis | Inflammatory Breast Carcinoma
Item
patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer
boolean
C0281267 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
lvef below 50% as determined by muga scan or echo
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Heart Disease | Cardiac abnormalities
Item
patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol
boolean
C0018799 (UMLS CUI [1])
C0018798 (UMLS CUI [2])
Gastrointestinal function Impaired | Gastrointestinal Disease Changing Absorption BKM120
Item
patient has impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bkm120
boolean
C0516983 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C3491291 (UMLS CUI [2,4])
Warfarin | Coumarin Derivative Anticoagulants
Item
patient is currently receiving warfarin or other coumarin derived anti-coagulants
boolean
C0043031 (UMLS CUI [1])
C0010206 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
C0003280 (UMLS CUI [2,3])
Adrenal Cortex Hormones chronic | Immunosuppressive Agents chronic
Item
patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
CYP3A Inhibitors Strong | CYP3A Inducers Strong
Item
patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of cyp3a
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850044 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
Score Anxiety Depressed mood Questionnaires
Item
patient has certain scores on an anxiety and depression mood questionnaires
boolean
C0449820 (UMLS CUI [1,1])
C0003467 (UMLS CUI [1,2])
C0344315 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling | Patients Contraceptive methods Unwilling
Item
pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
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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