ID

40878

Description

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

Keywords

Versions (1)
  1. 5/29/20 5/29/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 29, 2020

DOI

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License

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

English

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

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Gender | Age

Data type

boolean

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

ECOG performance status

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Bone Marrow function | Renal function | Liver function

Data type

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
Description

Able to swallow Oral medication

Data type

boolean

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

Exclusion Criteria

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

Systemic therapy Previous

Data type

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
Description

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

Data type

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
Description

Bilateral breast cancer | Neoplasm Metastasis | Inflammatory Breast Carcinoma

Data type

boolean

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

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

Data type

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
Description

Heart Disease | Cardiac abnormalities

Data type

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
Description

Gastrointestinal function Impaired | Gastrointestinal Disease Changing Absorption BKM120

Data type

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
Description

Warfarin | Coumarin Derivative Anticoagulants

Data type

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)
Description

Adrenal Cortex Hormones chronic | Immunosuppressive Agents chronic

Data type

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
Description

CYP3A Inhibitors Strong | CYP3A Inducers Strong

Data type

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
Description

Score Anxiety Depressed mood Questionnaires

Data type

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
Description

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

Data type

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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