ID

14805

Beskrivning

Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer; ODM derived from: https://clinicaltrials.gov/show/NCT02338531

Länk

https://clinicaltrials.gov/show/NCT02338531

Nyckelord

Versioner (1)
  1. 2016-04-29 2016-04-29 -
Uppladdad den

29 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02338531

Engelsk

Eligibility Breast Cancer NCT02338531

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥18 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. female.
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
3. histological diagnosis of triple-negative breast cancer (tnbc) breast adenocarcinoma (er<1%, pr<1% by (ihc) and her-2 0-1+ by ihc or ihc 2+ and fish or cish negative per updated asco guidelines).
Beskrivning

Triple-Negative Breast Cancer | Breast adenocarcinoma | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | Immunohistochemistry | erbB-2 Receptor | Fluorescent in Situ Hybridization Negative | Chromogenic in situ Hybridization Negative | ASCO Guidelines

Datatyp

boolean

Alias
UMLS CUI [1]
C2348819
UMLS CUI [2]
C0858252
UMLS CUI [3]
C2919271
UMLS CUI [4]
C2919590
UMLS CUI [5]
C0021044
UMLS CUI [6]
C0069515
UMLS CUI [7,1]
C0162789
UMLS CUI [7,2]
C0205160
UMLS CUI [8,1]
C1516514
UMLS CUI [8,2]
C0205160
UMLS CUI [9,1]
C1515948
UMLS CUI [9,2]
C0162791
4. no clinical or radiologic evidence of distant metastasis.
Beskrivning

Distant Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C1269798
5. presence of residual primary disease of at least 1.5 cm by u/s or mri within 14 days preceding the last cycle of standard anthracycline and taxane-based neoadjuvant chemotherapy.
Beskrivning

Primary disorders Residual | Ultrasonics (sound) | Magnetic Resonance Imaging | Anthracyclines Taxanes, antineoplastic Neoadjuvant Therapy Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C1609982
UMLS CUI [2]
C1456803
UMLS CUI [3]
C0024485
UMLS CUI [4,1]
C0282564
UMLS CUI [4,2]
C3541958
UMLS CUI [4,3]
C0600558
UMLS CUI [4,4]
C3665472
patients with synchronous synchronous bilateral cancer and unilateral multifocal or multicentric or bilateral disease breast cancer will be allowed provided histologic diagnosis of tnbc is found on all performed biopsies.
Beskrivning

bilateral breast cancer | Unilateral Breast Carcinoma Multifocal | Multicentric Breast Carcinoma | Triple-Negative Breast Cancer Finding | Biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2,1]
C1710547
UMLS CUI [2,2]
C0205292
UMLS CUI [3]
C2986664
UMLS CUI [4]
C2348819
UMLS CUI [5]
C0005558
6. completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. the use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed.
Beskrivning

Anthracyclines Taxanes, antineoplastic Neoadjuvant Therapy Chemotherapy Complete | Platinum-based Drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C3541958
UMLS CUI [1,3]
C0600558
UMLS CUI [1,4]
C3665472
UMLS CUI [1,5]
C0205197
UMLS CUI [2]
C2266918
7. ecog performance status (ps) 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. adequate bone marrow function: absolute neutrophil count (anc) ≥ 1500/μl or ≥1.5 x 109/l; platelets ≥100000/μl or ≥100 x 109/l; hemoglobin ≥ 9 g/dl.
Beskrivning

Bone Marrow Function | Absolute neutrophil count | Blood Platelets | Hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0542341
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0019046
9. adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal (uln) or estimated creatinine clearance ≥ 60 ml/min.
Beskrivning

Renal function | Creatinine measurement, serum | Upper Limit of Normal | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1519815
UMLS CUI [4]
C0373595
10. adequate liver function:total serum bilirubin ≤ 1.0 x uln or ≤ 2 x uln in cases of known gilberts syndrome; aspartate and alanine aminotransferase (ast and alt) ≤ 1.5 x uln; alkaline phosphatase ≤ 2.5 x uln.
Beskrivning

Liver function | Serum total bilirubin measurement | Upper Limit of Normal | Gilbert Disease | Aspartate Transaminase | Alanine Transaminase | Alkaline Phosphatase

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C1519815
UMLS CUI [4]
C0017551
UMLS CUI [5]
C0004002
UMLS CUI [6]
C0001899
UMLS CUI [7]
C0002059
11. for patients of childbearing potential: negative serum/urine pregnancy test and use accepted forms of non-hormonal contraception during the study period and up to 6 months after treatment completion.
Beskrivning

Childbearing Potential Serum pregnancy test negative Urine pregnancy test negative Hormonal contraception

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [1,3]
C0430057
UMLS CUI [1,4]
C2985296
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. concurrent anti-cancer therapy for current breast cancer (hormone therapy, chemotherapy, radiotherapy, immunotherapy). patients already included in another therapeutic trial involving an experimental drug.
Beskrivning

cancer treatment Breast Carcinoma | Hormone Therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Immunotherapy | Study Subject Participation Status Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0021083
UMLS CUI [6,1]
C2348568
UMLS CUI [6,2]
C0013230
2. pregnant or lactating women.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. any prior history of invasive breast cancer.
Beskrivning

History of invasive malignant neoplasm of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C4040792
4. any previous history of non-breast malignancies (excepted basal cell carcinoma or squamous cell carcinoma of the skin) in the preceding 5 years.
Beskrivning

H/O: malignant neoplasm | Basal cell carcinoma | Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0455471
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
5. known hypersensitivity to the study drug or excipients.
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
6. patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study.
Beskrivning

Comorbidity Study Subject Participation Status Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
7. subjects unable to swallow oral medications.
Beskrivning

Unable to swallow oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221470
UMLS CUI [1,2]
C0175795
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Similar models

Eligibility Breast Cancer NCT02338531

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥18 years old.
boolean
C0001779 (UMLS CUI [1])
Gender
Item
2. female.
boolean
C0079399 (UMLS CUI [1])
Triple-Negative Breast Cancer | Breast adenocarcinoma | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | Immunohistochemistry | erbB-2 Receptor | Fluorescent in Situ Hybridization Negative | Chromogenic in situ Hybridization Negative | ASCO Guidelines
Item
3. histological diagnosis of triple-negative breast cancer (tnbc) breast adenocarcinoma (er<1%, pr<1% by (ihc) and her-2 0-1+ by ihc or ihc 2+ and fish or cish negative per updated asco guidelines).
boolean
C2348819 (UMLS CUI [1])
C0858252 (UMLS CUI [2])
C2919271 (UMLS CUI [3])
C2919590 (UMLS CUI [4])
C0021044 (UMLS CUI [5])
C0069515 (UMLS CUI [6])
C0162789 (UMLS CUI [7,1])
C0205160 (UMLS CUI [7,2])
C1516514 (UMLS CUI [8,1])
C0205160 (UMLS CUI [8,2])
C1515948 (UMLS CUI [9,1])
C0162791 (UMLS CUI [9,2])
Distant Metastasis
Item
4. no clinical or radiologic evidence of distant metastasis.
boolean
C1269798 (UMLS CUI [1])
Primary disorders Residual | Ultrasonics (sound) | Magnetic Resonance Imaging | Anthracyclines Taxanes, antineoplastic Neoadjuvant Therapy Chemotherapy
Item
5. presence of residual primary disease of at least 1.5 cm by u/s or mri within 14 days preceding the last cycle of standard anthracycline and taxane-based neoadjuvant chemotherapy.
boolean
C0277554 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C1456803 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0282564 (UMLS CUI [4,1])
C3541958 (UMLS CUI [4,2])
C0600558 (UMLS CUI [4,3])
C3665472 (UMLS CUI [4,4])
bilateral breast cancer | Unilateral Breast Carcinoma Multifocal | Multicentric Breast Carcinoma | Triple-Negative Breast Cancer Finding | Biopsy
Item
patients with synchronous synchronous bilateral cancer and unilateral multifocal or multicentric or bilateral disease breast cancer will be allowed provided histologic diagnosis of tnbc is found on all performed biopsies.
boolean
C0281267 (UMLS CUI [1])
C1710547 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
C2986664 (UMLS CUI [3])
C2348819 (UMLS CUI [4])
C0005558 (UMLS CUI [5])
Anthracyclines Taxanes, antineoplastic Neoadjuvant Therapy Chemotherapy Complete | Platinum-based Drug
Item
6. completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. the use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed.
boolean
C0282564 (UMLS CUI [1,1])
C3541958 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
C3665472 (UMLS CUI [1,4])
C0205197 (UMLS CUI [1,5])
C2266918 (UMLS CUI [2])
ECOG performance status
Item
7. ecog performance status (ps) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Function | Absolute neutrophil count | Blood Platelets | Hemoglobin
Item
8. adequate bone marrow function: absolute neutrophil count (anc) ≥ 1500/μl or ≥1.5 x 109/l; platelets ≥100000/μl or ≥100 x 109/l; hemoglobin ≥ 9 g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Renal function | Creatinine measurement, serum | Upper Limit of Normal | Creatinine clearance measurement
Item
9. adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal (uln) or estimated creatinine clearance ≥ 60 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1519815 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Upper Limit of Normal | Gilbert Disease | Aspartate Transaminase | Alanine Transaminase | Alkaline Phosphatase
Item
10. adequate liver function:total serum bilirubin ≤ 1.0 x uln or ≤ 2 x uln in cases of known gilberts syndrome; aspartate and alanine aminotransferase (ast and alt) ≤ 1.5 x uln; alkaline phosphatase ≤ 2.5 x uln.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1519815 (UMLS CUI [3])
C0017551 (UMLS CUI [4])
C0004002 (UMLS CUI [5])
C0001899 (UMLS CUI [6])
C0002059 (UMLS CUI [7])
Childbearing Potential Serum pregnancy test negative Urine pregnancy test negative Hormonal contraception
Item
11. for patients of childbearing potential: negative serum/urine pregnancy test and use accepted forms of non-hormonal contraception during the study period and up to 6 months after treatment completion.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0430057 (UMLS CUI [1,3])
C2985296 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
cancer treatment Breast Carcinoma | Hormone Therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Immunotherapy | Study Subject Participation Status Investigational New Drugs
Item
1. concurrent anti-cancer therapy for current breast cancer (hormone therapy, chemotherapy, radiotherapy, immunotherapy). patients already included in another therapeutic trial involving an experimental drug.
boolean
C0920425 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C2348568 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
History of invasive malignant neoplasm of breast
Item
3. any prior history of invasive breast cancer.
boolean
C4040792 (UMLS CUI [1])
H/O: malignant neoplasm | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
4. any previous history of non-breast malignancies (excepted basal cell carcinoma or squamous cell carcinoma of the skin) in the preceding 5 years.
boolean
C0455471 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
5. known hypersensitivity to the study drug or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Comorbidity Study Subject Participation Status Limited
Item
6. patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Unable to swallow oral medication
Item
7. subjects unable to swallow oral medications.
boolean
C0221470 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
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