ID

44714

Beschrijving

HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT00412022

Link

https://clinicaltrials.gov/show/NCT00412022

Trefwoorden

Versies (2)
  1. 13-07-16 13-07-16 -
  2. 27-09-21 27-09-21 -
Geüploaded op

27 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00412022

Engels

Eligibility Breast Cancer NCT00412022

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of breast cancer
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
surgical resection of breast cancer (breast conserving surgery or mastectomy)
Beschrijving

Excision Breast Carcinoma | Breast-Conserving Surgery | Mastectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0917927
UMLS CUI [3]
C0024881
no evidence of disease
Beschrijving

Disease Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332120
indication for adjuvant hormonal therapy (er and/or pgr positive with ihc exam in at least 1% of primary tumor cells, according to st. gallen criteria)
Beschrijving

Indication Hormone Therapy Adjuvant | Estrogen receptor positive | progesterone receptor positive | Immunohistochemistry Tumor cells Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C1522673
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
UMLS CUI [4,1]
C0021044
UMLS CUI [4,2]
C0431085
UMLS CUI [4,3]
C0205225
patient age at least 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent . premenopausal status defined as lmp within 12 months of randomization (fsh, lh will not be considered as determinants of menopausal status due the chemotherapy induced reversible ovarian suppression)
Beschrijving

Informed Consent | Premenopausal | Last menstrual period | Follicle Stimulating Hormone | Luteinizing Hormone | Menopausal Status | Ovarian suppression Reversible Chemotherapy Induced

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0279752
UMLS CUI [2,2]
C0425932
UMLS CUI [3]
C0733758
UMLS CUI [4]
C0023607
UMLS CUI [5]
C3829127
UMLS CUI [6,1]
C0677922
UMLS CUI [6,2]
C0205343
UMLS CUI [6,3]
C0392920
UMLS CUI [6,4]
C0205263
please note that patients who have received neoadjuvant or adjuvant chemotherapy and/or locoregional radiation therapy may be included in the study
Beschrijving

Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Therapeutic radiology procedure Local | Therapeutic radiology procedure regional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [2]
C0085533
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205276
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205147
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
performance status (ecog)>2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
previous or concomitant malignancy (with the exception of adequately treated nonmalignant skin cancer and carcinoma in situ of the uterine cervix
Beschrijving

Malignant Neoplasms | Skin carcinoma Non-Malignant Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1518371
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0205411
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
metastatic breast cancer
Beschrijving

Carcinoma breast stage IV

Datatype

boolean

Alias
UMLS CUI [1]
C0278488
creatinine > 1.25 times the value of upper normal limit
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
pregnant or lactating females
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
clinical or radiologic evidence of bone fractures
Beschrijving

Bone Fracture Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C0332120
treatment with systemic cortisone therapy within 12 months prior to randomization
Beschrijving

Cortisone Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0010137
UMLS CUI [1,2]
C0205373
treatment with drugs that could alter bone metabolism (calcitonin, mithramycin, gallium nitrate) within 2 weeks prior to randomization
Beschrijving

Pharmaceutical Preparations Affecting bone metabolism | Calcitonin measurement | Plicamycin | gallium nitrate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596204
UMLS CUI [2]
C0201924
UMLS CUI [3]
C0026234
UMLS CUI [4]
C0061008
previous treatment with tamoxifen or aromatase inhibitors
Beschrijving

Tamoxifen | Aromatase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0593802
ast and/or alt > 3 times the value of upper normal limit with clinical and laboratory findings that indicate a grade of hepatic insufficiency that could potentially increase the risk of assuming letrozole
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Indication Hepatic Insufficiency | letrozole Risk

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1306571
UMLS CUI [4,1]
C0246421
UMLS CUI [4,2]
C0035647
any concomitant conditions that would, in the investigator's opinion, contraindicate the use of any of the drugs used in this study
Beschrijving

Comorbidity Medical contraindication Investigational New Drugs Use of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C1524063
inability to provide informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
inability to comply with followup
Beschrijving

Follow-up Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
patient undergoing invasive dental work at time of baseline evaluation or foreseen during the course of adjuvant therapy
Beschrijving

Invasive procedure Dental | Invasive procedure Dental Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038895
UMLS CUI [1,2]
C0226984
UMLS CUI [2,1]
C0038895
UMLS CUI [2,2]
C0226984
UMLS CUI [2,3]
C1301732
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Similar models

Eligibility Breast Cancer NCT00412022

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
histological diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Excision Breast Carcinoma | Breast-Conserving Surgery | Mastectomy
Item
surgical resection of breast cancer (breast conserving surgery or mastectomy)
boolean
C0728940 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0917927 (UMLS CUI [2])
C0024881 (UMLS CUI [3])
Disease Evidence of
Item
no evidence of disease
boolean
C0012634 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Indication Hormone Therapy Adjuvant | Estrogen receptor positive | progesterone receptor positive | Immunohistochemistry Tumor cells Primary
Item
indication for adjuvant hormonal therapy (er and/or pgr positive with ihc exam in at least 1% of primary tumor cells, according to st. gallen criteria)
boolean
C3146298 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C1522673 (UMLS CUI [1,3])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C0021044 (UMLS CUI [4,1])
C0431085 (UMLS CUI [4,2])
C0205225 (UMLS CUI [4,3])
Age
Item
patient age at least 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Premenopausal | Last menstrual period | Follicle Stimulating Hormone | Luteinizing Hormone | Menopausal Status | Ovarian suppression Reversible Chemotherapy Induced
Item
written informed consent . premenopausal status defined as lmp within 12 months of randomization (fsh, lh will not be considered as determinants of menopausal status due the chemotherapy induced reversible ovarian suppression)
boolean
C0021430 (UMLS CUI [1])
C0279752 (UMLS CUI [2,1])
C0425932 (UMLS CUI [2,2])
C0733758 (UMLS CUI [3])
C0023607 (UMLS CUI [4])
C3829127 (UMLS CUI [5])
C0677922 (UMLS CUI [6,1])
C0205343 (UMLS CUI [6,2])
C0392920 (UMLS CUI [6,3])
C0205263 (UMLS CUI [6,4])
Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Therapeutic radiology procedure Local | Therapeutic radiology procedure regional
Item
please note that patients who have received neoadjuvant or adjuvant chemotherapy and/or locoregional radiation therapy may be included in the study
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205276 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205147 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
ECOG performance status
Item
performance status (ecog)>2.
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma Non-Malignant Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate
Item
previous or concomitant malignancy (with the exception of adequately treated nonmalignant skin cancer and carcinoma in situ of the uterine cervix
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0205411 (UMLS CUI [2,4])
C0851140 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
Carcinoma breast stage IV
Item
metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine > 1.25 times the value of upper normal limit
boolean
C0201976 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Bone Fracture Evidence of
Item
clinical or radiologic evidence of bone fractures
boolean
C0016658 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Cortisone Systemic
Item
treatment with systemic cortisone therapy within 12 months prior to randomization
boolean
C0010137 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Pharmaceutical Preparations Affecting bone metabolism | Calcitonin measurement | Plicamycin | gallium nitrate
Item
treatment with drugs that could alter bone metabolism (calcitonin, mithramycin, gallium nitrate) within 2 weeks prior to randomization
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0201924 (UMLS CUI [2])
C0026234 (UMLS CUI [3])
C0061008 (UMLS CUI [4])
Tamoxifen | Aromatase Inhibitors
Item
previous treatment with tamoxifen or aromatase inhibitors
boolean
C0039286 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Indication Hepatic Insufficiency | letrozole Risk
Item
ast and/or alt > 3 times the value of upper normal limit with clinical and laboratory findings that indicate a grade of hepatic insufficiency that could potentially increase the risk of assuming letrozole
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C1306571 (UMLS CUI [3,2])
C0246421 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
Comorbidity Medical contraindication Investigational New Drugs Use of
Item
any concomitant conditions that would, in the investigator's opinion, contraindicate the use of any of the drugs used in this study
boolean
C0009488 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Follow-up Unable
Item
inability to comply with followup
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Invasive procedure Dental | Invasive procedure Dental Planned
Item
patient undergoing invasive dental work at time of baseline evaluation or foreseen during the course of adjuvant therapy
boolean
C0038895 (UMLS CUI [1,1])
C0226984 (UMLS CUI [1,2])
C0038895 (UMLS CUI [2,1])
C0226984 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
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