ID

37952

Beschrijving

Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01313039

Link

https://clinicaltrials.gov/show/NCT01313039

Trefwoorden

Versies (1)
  1. 02-09-19 02-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01313039

Engels

Eligibility Breast Cancer NCT01313039

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female breast cancer patient > 18 years.
Beschrijving

Gender | Breast Carcinoma | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0001779
patients must have biopsy-proven clinical stage ic-iii invasive breast carcinoma with
Beschrijving

Invasive carcinoma of breast TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
≤ 10% er expression by immunohistochemistry (ihc) analysis.
Beschrijving

Estrogen Receptor Expression Percentage Immunohistochemistry

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0021044
patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (er, protein/gene expression analysis).
Beschrijving

Pre treatment Core needle biopsy | Pre treatment Incisional biopsy | Estrogen Receptor Protein Expression Analysis | Estrogen Receptor Gene Expression Level Analysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C2709094
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C2709094
UMLS CUI [2,2]
C0184922
UMLS CUI [3,1]
C0034804
UMLS CUI [3,2]
C1882495
UMLS CUI [4,1]
C0034804
UMLS CUI [4,2]
C4521390
patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. planned procedure may include lumpectomy or mastectomy as clinically indicated.
Beschrijving

Tumor tissue sample Remaining Sufficient | Status post Biopsy | Requirement Operative Surgical Procedure Standard of Care | Indication Segmental Mastectomy | Indication Mastectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1527428
UMLS CUI [1,3]
C0205410
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C2936643
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0024885
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0024881
patients must have an ecog performance status of 0 - 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients must have the ability to understand and willingness to sign an english or a spanish language written informed consent document.
Beschrijving

Informed Consent English Language | Informed Consent Spanish Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0037750
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
male breast cancer patient.
Beschrijving

Gender | Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
Beschrijving

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Females & males of reproductive potential Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0036899
patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
Beschrijving

Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
patients should not have known or strongly suspected brca mutation by history (genetic testing not required).
Beschrijving

BRCA gene Mutation | BRCA gene Mutation Suspected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C0026882
UMLS CUI [2,1]
C0596223
UMLS CUI [2,2]
C0026882
UMLS CUI [2,3]
C0750491
patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.
Beschrijving

Requirement Pre-study Testing | Requirement Medical History | Requirement Physical Examination | Requirement Complete Blood Count | Requirement Measurement of renal function | Requirement Liver Function Tests | Patient Abnormality Ineligible

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C1527048
UMLS CUI [1,3]
C0039593
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0009555
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C2711919
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0023901
UMLS CUI [7,1]
C0030705
UMLS CUI [7,2]
C1704258
UMLS CUI [7,3]
C1512714
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Similar models

Eligibility Breast Cancer NCT01313039

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma | Age
Item
female breast cancer patient > 18 years.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Invasive carcinoma of breast TNM Breast tumor staging
Item
patients must have biopsy-proven clinical stage ic-iii invasive breast carcinoma with
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Estrogen Receptor Expression Percentage Immunohistochemistry
Item
≤ 10% er expression by immunohistochemistry (ihc) analysis.
boolean
C0034804 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
Pre treatment Core needle biopsy | Pre treatment Incisional biopsy | Estrogen Receptor Protein Expression Analysis | Estrogen Receptor Gene Expression Level Analysis
Item
patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (er, protein/gene expression analysis).
boolean
C2709094 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C2709094 (UMLS CUI [2,1])
C0184922 (UMLS CUI [2,2])
C0034804 (UMLS CUI [3,1])
C1882495 (UMLS CUI [3,2])
C0034804 (UMLS CUI [4,1])
C4521390 (UMLS CUI [4,2])
Tumor tissue sample Remaining Sufficient | Status post Biopsy | Requirement Operative Surgical Procedure Standard of Care | Indication Segmental Mastectomy | Indication Mastectomy
Item
patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. planned procedure may include lumpectomy or mastectomy as clinically indicated.
boolean
C0475358 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
C0205410 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C2936643 (UMLS CUI [3,3])
C3146298 (UMLS CUI [4,1])
C0024885 (UMLS CUI [4,2])
C3146298 (UMLS CUI [5,1])
C0024881 (UMLS CUI [5,2])
ECOG performance status
Item
patients must have an ecog performance status of 0 - 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent English Language | Informed Consent Spanish Language
Item
patients must have the ability to understand and willingness to sign an english or a spanish language written informed consent document.
boolean
C0021430 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Gender | Breast Carcinoma
Item
male breast cancer patient.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Females & males of reproductive potential Sexual Abstinence
Item
patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma
Item
patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
BRCA gene Mutation | BRCA gene Mutation Suspected
Item
patients should not have known or strongly suspected brca mutation by history (genetic testing not required).
boolean
C0596223 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0596223 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Requirement Pre-study Testing | Requirement Medical History | Requirement Physical Examination | Requirement Complete Blood Count | Requirement Measurement of renal function | Requirement Liver Function Tests | Patient Abnormality Ineligible
Item
patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.
boolean
C1514873 (UMLS CUI [1,1])
C1527048 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0009555 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C2711919 (UMLS CUI [5,2])
C1514873 (UMLS CUI [6,1])
C0023901 (UMLS CUI [6,2])
C0030705 (UMLS CUI [7,1])
C1704258 (UMLS CUI [7,2])
C1512714 (UMLS CUI [7,3])
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