ID

40994

Beschrijving

Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02089854

Link

https://clinicaltrials.gov/show/NCT02089854

Trefwoorden

Versies (1)
  1. 09-06-20 09-06-20 -
Houder van rechten

See clinicaltrials.gov

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9 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Female Breast Cancer NCT02089854

Engels

Eligibility Female Breast Cancer NCT02089854

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patients signed the written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
the patients present with histologically proven operable invasive breast cancers without distant metastasis.
Beschrijving

Invasive carcinoma of breast Operable | Distant metastasis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205188
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
the breast tumor's positive er/pr rate is <1%, and positive er-beta rate is ≥1% by immuno-histochemistry(ihc).
Beschrijving

Oestrogen receptor positive breast cancer Immunohistochemistry | Breast Carcinoma Progesterone receptor positive Immunohistochemistry | Breast Carcinoma Estrogen Receptor beta Positive Immunohistochemistry

Datatype

boolean

Alias
UMLS CUI [1,1]
C2938924
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0529099
UMLS CUI [3,3]
C1514241
UMLS CUI [3,4]
C0021044
the patients have no history of neoadjuvant hormone therapy.
Beschrijving

Hormone Therapy Neoadjuvant Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0332197
the patients' karnofsky performance score ≥70%.
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
female patient who is ≥ 18yrs, and ≤ 80yrs.
Beschrijving

Gender Age

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
the patients are non-pregnant, and disposed to practice contraception during the whole trial.
Beschrijving

Pregnancy Absent | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0700589
the patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer.
Beschrijving

Chemotherapy Neo-adjuvant | Operative Surgical Procedures | Modified radical mastectomy Directly | Breast-Conserving Surgery | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes | Status post Diagnosis Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1298676
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C0024883
UMLS CUI [3,2]
C1947931
UMLS CUI [4]
C0917927
UMLS CUI [5]
C0796693
UMLS CUI [6]
C0193867
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C0011900
UMLS CUI [7,3]
C0678222
the patients underwent chemotherapy, radiation therapy after surgery according to the 2013 nccn guideline.
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Status post Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
the results of patients' blood tests are as follows:
Beschrijving

Hematologic Tests

Datatype

boolean

Alias
UMLS CUI [1]
C0018941
hb≥90g/l; wbc≥4.0×109/l; neutrophils≥1.5×109/l; plt≥100×109/l; alanine aminotransferase(alt) and aspartate aminotransferase (ast) ≤ 2.5 × upper limit of normal(uln); total bilirubin(tbil) ≤ 1.5×uln; creatinine ≤ 1.25×uln.
Beschrijving

Hemoglobin measurement | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C1278039
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patients have a previous history of invasive malignant disease (breast cancer at any time, other malignant disorders within the past 10 years excluding squamous or basal-cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied).
Beschrijving

Malignant disease Invasive | Breast Carcinoma | Cancer Other | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Conization Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442867
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0678222
UMLS CUI [3]
C1707251
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0195324
UMLS CUI [6,3]
C0851140
the patients have any severe concomitant disease which will place the patient at unusual risk or confound the results of the trial.
Beschrijving

Comorbidity Severe At risk Patient | Comorbidity Severe Interferes with Research results

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0030705
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0683954
the patients have history of neoadjuvant hormone therapy.
Beschrijving

Hormone Therapy Neoadjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
the patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
Beschrijving

Cancer treatment | Study Subject Participation Status | Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0008976
the patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
Beschrijving

Pregnancy | Breast Feeding | Contraceptive methods Refused

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1705116
the patients are unwilling to stop any hormonal drug including hormone replacement therapy(hrt).
Beschrijving

Hormone drug Discontinue Unwilling | Hormone replacement therapy Discontinue Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019932
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0282402
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
the patients can't understand the written informed consent; such as they have dementia.
Beschrijving

Informed Consent Comprehension Unable | Dementia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0497327
the patients have allergic history or contraindication of toremifene/anastrozole.
Beschrijving

Hypersensitivity Toremifene | Medical contraindication Toremifene | Hypersensitivity Anastrozole | Medical contraindication Anastrozole

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0076836
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0076836
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0290883
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0290883
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Similar models

Eligibility Female Breast Cancer NCT02089854

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
the patients signed the written informed consent.
boolean
C0021430 (UMLS CUI [1])
Invasive carcinoma of breast Operable | Distant metastasis Absent
Item
the patients present with histologically proven operable invasive breast cancers without distant metastasis.
boolean
C0853879 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Oestrogen receptor positive breast cancer Immunohistochemistry | Breast Carcinoma Progesterone receptor positive Immunohistochemistry | Breast Carcinoma Estrogen Receptor beta Positive Immunohistochemistry
Item
the breast tumor's positive er/pr rate is <1%, and positive er-beta rate is ≥1% by immuno-histochemistry(ihc).
boolean
C2938924 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C0529099 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0021044 (UMLS CUI [3,4])
Hormone Therapy Neoadjuvant Absent
Item
the patients have no history of neoadjuvant hormone therapy.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
the patients' karnofsky performance score ≥70%.
boolean
C0206065 (UMLS CUI [1])
Gender Age
Item
female patient who is ≥ 18yrs, and ≤ 80yrs.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Pregnancy Absent | Contraceptive methods
Item
the patients are non-pregnant, and disposed to practice contraception during the whole trial.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
Chemotherapy Neo-adjuvant | Operative Surgical Procedures | Modified radical mastectomy Directly | Breast-Conserving Surgery | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes | Status post Diagnosis Breast Carcinoma
Item
the patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0024883 (UMLS CUI [3,1])
C1947931 (UMLS CUI [3,2])
C0917927 (UMLS CUI [4])
C0796693 (UMLS CUI [5])
C0193867 (UMLS CUI [6])
C0231290 (UMLS CUI [7,1])
C0011900 (UMLS CUI [7,2])
C0678222 (UMLS CUI [7,3])
Chemotherapy | Therapeutic radiology procedure | Status post Operative Surgical Procedures
Item
the patients underwent chemotherapy, radiation therapy after surgery according to the 2013 nccn guideline.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Hematologic Tests
Item
the results of patients' blood tests are as follows:
boolean
C0018941 (UMLS CUI [1])
Hemoglobin measurement | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
hb≥90g/l; wbc≥4.0×109/l; neutrophils≥1.5×109/l; plt≥100×109/l; alanine aminotransferase(alt) and aspartate aminotransferase (ast) ≤ 2.5 × upper limit of normal(uln); total bilirubin(tbil) ≤ 1.5×uln; creatinine ≤ 1.25×uln.
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Malignant disease Invasive | Breast Carcinoma | Cancer Other | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Conization Carcinoma in situ of uterine cervix
Item
the patients have a previous history of invasive malignant disease (breast cancer at any time, other malignant disorders within the past 10 years excluding squamous or basal-cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied).
boolean
C0442867 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C1707251 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0195324 (UMLS CUI [6,2])
C0851140 (UMLS CUI [6,3])
Comorbidity Severe At risk Patient | Comorbidity Severe Interferes with Research results
Item
the patients have any severe concomitant disease which will place the patient at unusual risk or confound the results of the trial.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Hormone Therapy Neoadjuvant
Item
the patients have history of neoadjuvant hormone therapy.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
Cancer treatment | Study Subject Participation Status | Clinical Trial
Item
the patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
boolean
C0920425 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0008976 (UMLS CUI [3])
Pregnancy | Breast Feeding | Contraceptive methods Refused
Item
the patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Hormone drug Discontinue Unwilling | Hormone replacement therapy Discontinue Unwilling
Item
the patients are unwilling to stop any hormonal drug including hormone replacement therapy(hrt).
boolean
C0019932 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0282402 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Informed Consent Comprehension Unable | Dementia
Item
the patients can't understand the written informed consent; such as they have dementia.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0497327 (UMLS CUI [2])
Hypersensitivity Toremifene | Medical contraindication Toremifene | Hypersensitivity Anastrozole | Medical contraindication Anastrozole
Item
the patients have allergic history or contraindication of toremifene/anastrozole.
boolean
C0020517 (UMLS CUI [1,1])
C0076836 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0076836 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0290883 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0290883 (UMLS CUI [4,2])
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