ID

29827

Beschreibung

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01007942

Link

https://clinicaltrials.gov/show/NCT01007942

Stichworte

Versionen (1)
  1. 22.04.18 22.04.18 -
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See clinicaltrials.gov

Hochgeladen am

22. April 2018

DOI

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Eligibility HER2/Neu Over-expressing Locally Advanced Breast Cancer NCT01007942

Englisch

Eligibility HER2/Neu Over-expressing Locally Advanced Breast Cancer NCT01007942

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. locally recurrent disease must not be amenable to resection with curative intent.
Beschreibung

Invasive carcinoma of breast | Recurrent disease Locally | Neoplasm Metastasis Radiology | Recurrent disease Inappropriate Excision Curative

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1517927
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0043299
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0728940
UMLS CUI [4,4]
C1276305
her2+ status defined as ihc 3+ staining or in situ hybridization positive
Beschreibung

HER2/Neu Positive Immunohistochemistry | Staining method Positive | Fluorescent in situ hybridisation positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0487602
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C3495875
patients with resistance to trastuzumab
Beschreibung

Trastuzumab Resistance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1514892
prior taxane therapy
Beschreibung

Taxane

Datentyp

boolean

Alias
UMLS CUI [1]
C0215136
patients with an ecog performance status of 0 - 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patients with measurable disease as per recist criteria
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
Beschreibung

Childbearing Potential Pregnancy test negative | Premenopausal state Sexually active Contraceptive methods | Estrogen Contraceptive Agents Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C0009907
UMLS CUI [3,2]
C0332196
patients must meet laboratory criteria defined in the study within 21 days prior to randomization
Beschreibung

Laboratory Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior mtor inhibitors or vinca alkaloid agents for the treatment of cancer
Beschreibung

mTOR Inhibitors Cancer treatment | Vinca Alkaloids Cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515672
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0042672
UMLS CUI [2,2]
C0920425
more than three prior chemotherapy lines for advanced disease.
Beschreibung

Chemotherapy Quantity Advanced disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
symptomatic cns metastases or evidence of leptomeningeal disease. previously treated asymptomatic cns metastases are allowed provided that the last treatment for cns metastases was completed >8 weeks prior to randomization
Beschreibung

CNS metastases Symptomatic | Leptomeningeal disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0751297
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral everolimus
Beschreibung

Gastrointestinal function Impaired | Gastrointestinal Disease Changing Absorption Everolimus Oral Product

Datentyp

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]
C3218081
peripheral neuropathy ≥ grade 2 at randomization
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
active cardiac disease
Beschreibung

Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
history of cardiac dysfunction
Beschreibung

Cardiac dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3277906
any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
Beschreibung

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma Treated | Exception Skin carcinoma Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007137
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699893
UMLS CUI [5,3]
C1522326
known hypersensitivity to any study medication
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
breastfeeding or pregnant
Beschreibung

Breast Feeding | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
other protocol-defined inclusion/exclusion criteria may ap
Beschreibung

Clinical Trial Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility HER2/Neu Over-expressing Locally Advanced Breast Cancer NCT01007942

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Recurrent disease Locally | Neoplasm Metastasis Radiology | Recurrent disease Inappropriate Excision Curative
Item
histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. locally recurrent disease must not be amenable to resection with curative intent.
boolean
C0853879 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0043299 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0728940 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
HER2/Neu Positive Immunohistochemistry | Staining method Positive | Fluorescent in situ hybridisation positive
Item
her2+ status defined as ihc 3+ staining or in situ hybridization positive
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0487602 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C3495875 (UMLS CUI [3])
Trastuzumab Resistance
Item
patients with resistance to trastuzumab
boolean
C0728747 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
Taxane
Item
prior taxane therapy
boolean
C0215136 (UMLS CUI [1])
ECOG performance status
Item
patients with an ecog performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
patients with measurable disease as per recist criteria
boolean
C1513041 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Premenopausal state Sexually active Contraceptive methods | Estrogen Contraceptive Agents Excluded
Item
documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009907 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Laboratory Criteria Fulfill
Item
patients must meet laboratory criteria defined in the study within 21 days prior to randomization
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
mTOR Inhibitors Cancer treatment | Vinca Alkaloids Cancer treatment
Item
prior mtor inhibitors or vinca alkaloid agents for the treatment of cancer
boolean
C1515672 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0042672 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
Chemotherapy Quantity Advanced disease
Item
more than three prior chemotherapy lines for advanced disease.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
CNS metastases Symptomatic | Leptomeningeal disease
Item
symptomatic cns metastases or evidence of leptomeningeal disease. previously treated asymptomatic cns metastases are allowed provided that the last treatment for cns metastases was completed >8 weeks prior to randomization
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2])
Gastrointestinal function Impaired | Gastrointestinal Disease Changing Absorption Everolimus Oral Product
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral everolimus
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])
C3218081 (UMLS CUI [2,4])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy ≥ grade 2 at randomization
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Heart Disease
Item
active cardiac disease
boolean
C0018799 (UMLS CUI [1])
Cardiac dysfunction
Item
history of cardiac dysfunction
boolean
C3277906 (UMLS CUI [1])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma Treated | Exception Skin carcinoma Treated
Item
any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007137 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Hypersensitivity Investigational New Drugs
Item
known hypersensitivity to any study medication
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may ap
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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