ID

38220

Beskrivning

A Study of Perjeta (Pertuzumab) and Herceptin (Trastuzumab) Treatment in Combination With a Taxane in Patients With Advanced HER2-positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02019277

Länk

https://clinicaltrials.gov/show/NCT02019277

Nyckelord

Versioner (1)
  1. 2019-09-29 2019-09-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02019277

Engelsk

Eligibility Breast Cancer NCT02019277

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male patients aged >/= 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
her2-positive disease, with an immunohistochemistry score of 3+ or ish-positive on primary tumour or metastatic site
Beskrivning

Disease HER2 Positive Immunohistochemistry | Primary tumor In Situ Hybridization Positive | Metastatic cancer site In Situ Hybridization Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0162788
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0280457
UMLS CUI [3,2]
C0162788
UMLS CUI [3,3]
C1514241
histologically or cytologically confirmed metastatic breast cancer (mbc) with at least one measurable lesion and/or non-measurable disease according to recist version 1.1
Beskrivning

Secondary malignant neoplasm of female breast | Measurable lesion Quantity | Non-Measurable Lesion Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1334988
UMLS CUI [3,2]
C1265611
eastern cooperative oncology group (ecog) performance status 0-2 for patients who will receive paclitaxel or nab-paclitaxel chemotherapy and ecog 0-1 for patients who will receive docetaxel chemotherapy
Beskrivning

ECOG performance status | Chemotherapy | Paclitaxel | nab-paclitaxel | docetaxel

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0144576
UMLS CUI [4]
C1527223
UMLS CUI [5]
C0246415
lvef of >/= 50% measured by echocardiography (echo) or multiple-gated acquisition (muga) scan before the first doses of pertuzumab and trastuzumab.
Beskrivning

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan | Status pre- Pertuzumab Dosage | Status pre- Trastuzumab Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C1328025
UMLS CUI [3,3]
C0178602
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C0728747
UMLS CUI [4,3]
C0178602
previous use of either adjuvant or neoadjuvant anti-her2 therapy is allowed
Beskrivning

Targeted Therapy Adjuvant HER2 | Neoadjuvant Targeted Therapy HER2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C0069515
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C2985566
UMLS CUI [2,3]
C0069515
hormonal therapy will be allowed as per institutional guidelines (administered after completion of taxane chemotherapy)
Beskrivning

Hormone Therapy | Status post Completion Taxane Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0215136
UMLS CUI [2,4]
C3665472
use of effective contraception as defined by the protocol
Beskrivning

Contraceptive methods | Definition Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C1704788
UMLS CUI [2,2]
C2348563
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous systemic non-hormonal anticancer therapy for treatment of mbc
Beskrivning

Cancer treatment Systemic Secondary malignant neoplasm of female breast | Exception Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0346993
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279025
history of other cancers. patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively-treated cancers who have been disease-free for at least 5 years are eligible. patients with previous ductal carcinoma in situ (dcis) of the breast are also eligible for the study
Beskrivning

Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration | Exception DCIS Previous

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C1707251
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0007124
UMLS CUI [6,3]
C0205156
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current peripheral neuropathy of grade 3 or greater (national cancer institute common terminology criteria for adverse events [nci ctcae] version 4.0)
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
radiographic evidence of central nervous system (cns) metastases as assessed by computed tomography (ct) or magnetic resonance imaging (mri), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment
Beskrivning

CNS metastases CT | CNS metastases MRI | Exception CNS metastases Treated | Exception CNS metastases Stable | Exception Steroid therapy Redundant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0686377
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0686377
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0149783
UMLS CUI [5,3]
C1313915
patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
Beskrivning

Comorbidity Serious Interferes with Planned Treatment | Lung disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C3641097
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205082
inadequate organ function
Beskrivning

Organ function Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205412
serious cardiac illness or medical conditions that would preclude the use of trastuzumab
Beskrivning

Heart Disease Serious | Medical condition Excludes Trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0728747
patients with severe breathing difficulties at rest or requiring supplementary oxygen therapy
Beskrivning

Resting Dyspnea | Requirement Oxygen supplementation

Datatyp

boolean

Alias
UMLS CUI [1]
C0743330
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0919655
concurrent enrolment in another clinical study using an investigational anti-cancer treatment, within 28 days before the first doses of herceptin and perjeta
Beskrivning

Study Subject Participation Status | Cancer treatment Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1517586
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Similar models

Eligibility Breast Cancer NCT02019277

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
female and male patients aged >/= 18 years
boolean
C0001779 (UMLS CUI [1])
Disease HER2 Positive Immunohistochemistry | Primary tumor In Situ Hybridization Positive | Metastatic cancer site In Situ Hybridization Positive
Item
her2-positive disease, with an immunohistochemistry score of 3+ or ish-positive on primary tumour or metastatic site
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C0162788 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0280457 (UMLS CUI [3,1])
C0162788 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Secondary malignant neoplasm of female breast | Measurable lesion Quantity | Non-Measurable Lesion Quantity
Item
histologically or cytologically confirmed metastatic breast cancer (mbc) with at least one measurable lesion and/or non-measurable disease according to recist version 1.1
boolean
C0346993 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1334988 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
ECOG performance status | Chemotherapy | Paclitaxel | nab-paclitaxel | docetaxel
Item
eastern cooperative oncology group (ecog) performance status 0-2 for patients who will receive paclitaxel or nab-paclitaxel chemotherapy and ecog 0-1 for patients who will receive docetaxel chemotherapy
boolean
C1520224 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0144576 (UMLS CUI [3])
C1527223 (UMLS CUI [4])
C0246415 (UMLS CUI [5])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan | Status pre- Pertuzumab Dosage | Status pre- Trastuzumab Dosage
Item
lvef of >/= 50% measured by echocardiography (echo) or multiple-gated acquisition (muga) scan before the first doses of pertuzumab and trastuzumab.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C1328025 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0332152 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
Targeted Therapy Adjuvant HER2 | Neoadjuvant Targeted Therapy HER2
Item
previous use of either adjuvant or neoadjuvant anti-her2 therapy is allowed
boolean
C2985566 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
C0069515 (UMLS CUI [2,3])
Hormone Therapy | Status post Completion Taxane Chemotherapy
Item
hormonal therapy will be allowed as per institutional guidelines (administered after completion of taxane chemotherapy)
boolean
C0279025 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0215136 (UMLS CUI [2,3])
C3665472 (UMLS CUI [2,4])
Contraceptive methods | Definition Study Protocol
Item
use of effective contraception as defined by the protocol
boolean
C0700589 (UMLS CUI [1])
C1704788 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic Secondary malignant neoplasm of female breast | Exception Hormone Therapy
Item
previous systemic non-hormonal anticancer therapy for treatment of mbc
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration | Exception DCIS Previous
Item
history of other cancers. patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively-treated cancers who have been disease-free for at least 5 years are eligible. patients with previous ductal carcinoma in situ (dcis) of the breast are also eligible for the study
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0007124 (UMLS CUI [6,2])
C0205156 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
current peripheral neuropathy of grade 3 or greater (national cancer institute common terminology criteria for adverse events [nci ctcae] version 4.0)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
CNS metastases CT | CNS metastases MRI | Exception CNS metastases Treated | Exception CNS metastases Stable | Exception Steroid therapy Redundant
Item
radiographic evidence of central nervous system (cns) metastases as assessed by computed tomography (ct) or magnetic resonance imaging (mri), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment
boolean
C0686377 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0686377 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0686377 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0149783 (UMLS CUI [5,2])
C1313915 (UMLS CUI [5,3])
Comorbidity Serious Interferes with Planned Treatment | Lung disease Severe
Item
patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3641097 (UMLS CUI [1,4])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Organ function Inadequate
Item
inadequate organ function
boolean
C0678852 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Heart Disease Serious | Medical condition Excludes Trastuzumab
Item
serious cardiac illness or medical conditions that would preclude the use of trastuzumab
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0728747 (UMLS CUI [2,3])
Resting Dyspnea | Requirement Oxygen supplementation
Item
patients with severe breathing difficulties at rest or requiring supplementary oxygen therapy
boolean
C0743330 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0919655 (UMLS CUI [2,2])
Study Subject Participation Status | Cancer treatment Investigational
Item
concurrent enrolment in another clinical study using an investigational anti-cancer treatment, within 28 days before the first doses of herceptin and perjeta
boolean
C2348568 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
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