ID

41174

Beskrivning

The BEACON Study (Breast Cancer Outcomes With NKTR-102); ODM derived from: https://clinicaltrials.gov/show/NCT01492101

Länk

https://clinicaltrials.gov/show/NCT01492101

Nyckelord

Versioner (1)
  1. 2020-07-05 2020-07-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 juli 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Locally Recurrent Breast Cancer NCT01492101

Engelsk

Eligibility Locally Recurrent Breast Cancer NCT01492101

1 Formulär  
Criteria
Beskrivning

Criteria

patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated
Beskrivning

Adult | Gender | Breast Carcinoma | Indication Cytotoxic Chemotherapy Single Agent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0678222
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0677881
UMLS CUI [4,3]
C4763675
patient can have either measurable or non-measurable disease by recist.
Beskrivning

Measurable Disease | Disease Non-Measurable

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1518373
patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
Beskrivning

Prior Therapy Neoadjuvant | Prior Therapy Adjuvant | Prior Therapy Neoplasm Metastasis | Anthracyclines | taxane | capecitabine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1522673
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0027627
UMLS CUI [4]
C0282564
UMLS CUI [5]
C0215136
UMLS CUI [6]
C0671970
patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. a minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. all therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.
Beskrivning

Cytotoxic Chemotherapy Quantity Locally Recurrent Malignant Neoplasm | Cytotoxic Chemotherapy Quantity Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2986682
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
patient has eastern cooperative oncology group (ecog) performance status of 0 or 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematopoietic, liver and kidney functions.
Beskrivning

Function Hematopoietic | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031843
UMLS CUI [1,2]
C0229601
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
exclusion criteria (major highlights):
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Biological treatment | Hormone Therapy | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0949266
patient with any major surgery within 28 days prior to randomization.
Beskrivning

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
Beskrivning

Biological agents Cancer treatment | Antibodies | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0920425
UMLS CUI [2]
C0003241
UMLS CUI [3]
C0013230
patient with prior treatment for cancer with a camptothecin derivative.
Beskrivning

Cancer treatment Previous | Camptothecin Derivative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0006812
UMLS CUI [2,2]
C1527240
patient with chronic or acute gi disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
Beskrivning

Gastrointestinal Diseases chronic | Gastrointestinal Diseases | Diarrhea CTCAE Grades | Antidiarrheal supportive care chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0017178
UMLS CUI [3,1]
C0011991
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C0853588
UMLS CUI [4,2]
C0205191
patient received pharmacotherapy for hepatitis b or c, tuberculosis or hiv.
Beskrivning

Pharmacotherapy Hepatitis B | Pharmacotherapy Hepatitis C | Pharmacotherapy Tuberculosis | Pharmacotherapy HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C0041296
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0019693
patient with known cirrhosis diagnosed with child-pugh class a or higher liver disease.
Beskrivning

Liver Cirrhosis | Liver disease Child-Pugh Clinical Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C4050412
patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
Beskrivning

Malignant Neoplasm | Exception Breast Carcinoma | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of bladder | Exception Definitive Treatment Previous

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0154091
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C2986592
UMLS CUI [6,3]
C0205156
patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
Beskrivning

Patient need for Oxygen supplementation Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0919655
UMLS CUI [1,3]
C0332173
patients with significant cardiovascular impairment.
Beskrivning

Cardiovascular impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C0848757
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Similar models

Eligibility Locally Recurrent Breast Cancer NCT01492101

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Adult | Gender | Breast Carcinoma | Indication Cytotoxic Chemotherapy Single Agent
Item
patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0678222 (UMLS CUI [3])
C3146298 (UMLS CUI [4,1])
C0677881 (UMLS CUI [4,2])
C4763675 (UMLS CUI [4,3])
Measurable Disease | Disease Non-Measurable
Item
patient can have either measurable or non-measurable disease by recist.
boolean
C1513041 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1518373 (UMLS CUI [2,2])
Prior Therapy Neoadjuvant | Prior Therapy Adjuvant | Prior Therapy Neoplasm Metastasis | Anthracyclines | taxane | capecitabine
Item
patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
boolean
C1514463 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0282564 (UMLS CUI [4])
C0215136 (UMLS CUI [5])
C0671970 (UMLS CUI [6])
Cytotoxic Chemotherapy Quantity Locally Recurrent Malignant Neoplasm | Cytotoxic Chemotherapy Quantity Neoplasm Metastasis
Item
patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. a minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. all therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2986682 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
ECOG performance status
Item
patient has eastern cooperative oncology group (ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Function Hematopoietic | Liver function | Renal function
Item
adequate hematopoietic, liver and kidney functions.
boolean
C0031843 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Exclusion Criteria Main
Item
exclusion criteria (major highlights):
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Chemotherapy | Therapeutic radiology procedure | Biological treatment | Hormone Therapy | Therapy, Investigational
Item
patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0949266 (UMLS CUI [5])
Major surgery
Item
patient with any major surgery within 28 days prior to randomization.
boolean
C0679637 (UMLS CUI [1])
Biological agents Cancer treatment | Antibodies | Investigational New Drugs
Item
patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
boolean
C0005515 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0003241 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Cancer treatment Previous | Camptothecin Derivative
Item
patient with prior treatment for cancer with a camptothecin derivative.
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006812 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
Gastrointestinal Diseases chronic | Gastrointestinal Diseases | Diarrhea CTCAE Grades | Antidiarrheal supportive care chronic
Item
patient with chronic or acute gi disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
boolean
C0017178 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2])
C0011991 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0853588 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Pharmacotherapy Hepatitis B | Pharmacotherapy Hepatitis C | Pharmacotherapy Tuberculosis | Pharmacotherapy HIV Infection
Item
patient received pharmacotherapy for hepatitis b or c, tuberculosis or hiv.
boolean
C0013216 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0013216 (UMLS CUI [3,1])
C0041296 (UMLS CUI [3,2])
C0013216 (UMLS CUI [4,1])
C0019693 (UMLS CUI [4,2])
Liver Cirrhosis | Liver disease Child-Pugh Clinical Classification
Item
patient with known cirrhosis diagnosed with child-pugh class a or higher liver disease.
boolean
C0023890 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C4050412 (UMLS CUI [2,2])
Malignant Neoplasm | Exception Breast Carcinoma | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of bladder | Exception Definitive Treatment Previous
Item
patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0154091 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C2986592 (UMLS CUI [6,2])
C0205156 (UMLS CUI [6,3])
Patient need for Oxygen supplementation Daily
Item
patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
boolean
C0686904 (UMLS CUI [1,1])
C0919655 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Cardiovascular impairment
Item
patients with significant cardiovascular impairment.
boolean
C0848757 (UMLS CUI [1])
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