ID

41164

Beschrijving

Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01847001

Link

https://clinicaltrials.gov/show/NCT01847001

Trefwoorden

Versies (1)
  1. 03-07-20 03-07-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 juli 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Locally Advanced Breast Cancer NCT01847001

Engels

Eligibility Locally Advanced Breast Cancer NCT01847001

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
english or spanish speaking women age ≥18
Beschrijving

Able to speak English Language | Able to speak Spanish Language | Gender | Age

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
heart rate > 60 bpm
Beschrijving

Heart rate

Datatype

boolean

Alias
UMLS CUI [1]
C0018810
systolic blood pressure > 100 mm/hg
Beschrijving

Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.
Beschrijving

Neoadjuvant Chemotherapy | Chemotherapy cycle Quantity | taxane | Paclitaxel Dose | Abraxane Dose | Adriamycin Dose | Cyclophosphamide Dose | Growth Factor Support

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0215136
UMLS CUI [4,1]
C0144576
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C1564985
UMLS CUI [5,2]
C0178602
UMLS CUI [6,1]
C0085752
UMLS CUI [6,2]
C0178602
UMLS CUI [7,1]
C0010583
UMLS CUI [7,2]
C0178602
UMLS CUI [8,1]
C0018284
UMLS CUI [8,2]
C1521721
echocardiogram (echo) or multiple-gated acquisition scan (muga) with ejection fraction > 50%.
Beschrijving

Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (her2) +/- breast cancer are eligible
Beschrijving

Hormone Receptor Positive Breast Carcinoma | Breast Carcinoma Hormone Receptor Negative | HER2-positive carcinoma of breast | HER2-negative breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C4745240
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0019929
UMLS CUI [2,3]
C1513916
UMLS CUI [3]
C1960398
UMLS CUI [4]
C4733095
if a patient has her2-positive breast cancer, herceptin and perjeta will be given along with taxane therapy
Beschrijving

HER2-positive carcinoma of breast | Herceptin | Perjeta | taxane

Datatype

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C0338204
UMLS CUI [3]
C3473371
UMLS CUI [4]
C0215136
any stage invasive breast cancer provided the primary breast tumor size is ≥ 1 cm
Beschrijving

Invasive carcinoma of breast TNM Breast tumor staging | Breast Carcinoma Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0456389
agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)
Beschrijving

Collection of blood specimen

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. the biopsy prior to taxol #1 is optional.
Beschrijving

Core biopsy Evaluation | Evaluation Tissue Excisional | Biomarkers

Datatype

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1261322
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0040300
UMLS CUI [2,3]
C0728940
UMLS CUI [3]
C0005516
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients failing to meet the inclusion criteria
Beschrijving

Inclusion criteria Failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231175
corrected qt interval (qtc) prolongation as defined by > 470 milliseconds on electrocardiogram (ecg)
Beschrijving

Prolonged QTc interval on electrocardiogram (ECG)

Datatype

boolean

Alias
UMLS CUI [1]
C4015677
first degree av block on ecg in which pr interval lengthened > 200 milliseconds; second degree; or third degree
Beschrijving

First degree atrioventricular block ECG | Second degree atrioventricular block ECG | Complete atrioventricular block ECG | Prolonged PR interval

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085614
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C0264906
UMLS CUI [2,2]
C0013798
UMLS CUI [3,1]
C0151517
UMLS CUI [3,2]
C0013798
UMLS CUI [4]
C0600125
on beta-blocker treatment. if discontinued, patients must have been off beta-blockers for at least 3 months.
Beschrijving

Adrenergic beta-1 Receptor Antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C0304516
history of asthma, given concern for β-blockade in this population
Beschrijving

History of asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0455544
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Similar models

Eligibility Locally Advanced Breast Cancer NCT01847001

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Able to speak English Language | Able to speak Spanish Language | Gender | Age
Item
english or spanish speaking women age ≥18
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Heart rate
Item
heart rate > 60 bpm
boolean
C0018810 (UMLS CUI [1])
Systolic Pressure
Item
systolic blood pressure > 100 mm/hg
boolean
C0871470 (UMLS CUI [1])
Neoadjuvant Chemotherapy | Chemotherapy cycle Quantity | taxane | Paclitaxel Dose | Abraxane Dose | Adriamycin Dose | Cyclophosphamide Dose | Growth Factor Support
Item
deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3])
C0144576 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1564985 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0085752 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0010583 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0018284 (UMLS CUI [8,1])
C1521721 (UMLS CUI [8,2])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan
Item
echocardiogram (echo) or multiple-gated acquisition scan (muga) with ejection fraction > 50%.
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Hormone Receptor Positive Breast Carcinoma | Breast Carcinoma Hormone Receptor Negative | HER2-positive carcinoma of breast | HER2-negative breast cancer
Item
patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (her2) +/- breast cancer are eligible
boolean
C4745240 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C1960398 (UMLS CUI [3])
C4733095 (UMLS CUI [4])
HER2-positive carcinoma of breast | Herceptin | Perjeta | taxane
Item
if a patient has her2-positive breast cancer, herceptin and perjeta will be given along with taxane therapy
boolean
C1960398 (UMLS CUI [1])
C0338204 (UMLS CUI [2])
C3473371 (UMLS CUI [3])
C0215136 (UMLS CUI [4])
Invasive carcinoma of breast TNM Breast tumor staging | Breast Carcinoma Size
Item
any stage invasive breast cancer provided the primary breast tumor size is ≥ 1 cm
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Collection of blood specimen
Item
agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)
boolean
C0005834 (UMLS CUI [1])
Core biopsy Evaluation | Evaluation Tissue Excisional | Biomarkers
Item
agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. the biopsy prior to taxol #1 is optional.
boolean
C1318309 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0040300 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C0005516 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Failed
Item
patients failing to meet the inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Prolonged QTc interval on electrocardiogram (ECG)
Item
corrected qt interval (qtc) prolongation as defined by > 470 milliseconds on electrocardiogram (ecg)
boolean
C4015677 (UMLS CUI [1])
First degree atrioventricular block ECG | Second degree atrioventricular block ECG | Complete atrioventricular block ECG | Prolonged PR interval
Item
first degree av block on ecg in which pr interval lengthened > 200 milliseconds; second degree; or third degree
boolean
C0085614 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0264906 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
C0151517 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
C0600125 (UMLS CUI [4])
Adrenergic beta-1 Receptor Antagonists
Item
on beta-blocker treatment. if discontinued, patients must have been off beta-blockers for at least 3 months.
boolean
C0304516 (UMLS CUI [1])
History of asthma
Item
history of asthma, given concern for β-blockade in this population
boolean
C0455544 (UMLS CUI [1])
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