ID

38042

Beskrivning

Trial of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in HER2-negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01537536

Länk

https://clinicaltrials.gov/show/NCT01537536

Nyckelord

Versioner (1)
  1. 2019-09-11 2019-09-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 september 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01537536

Engelsk

Eligibility Breast Cancer NCT01537536

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. newly diagnosed histologically confirmed bc with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
Beskrivning

Breast Carcinoma | Invasive carcinoma of breast Operable TNM Breast tumor staging | Invasive carcinoma of breast Advanced Locally TNM Breast tumor staging | Invasive carcinoma of breast inflammatory TNM Breast tumor staging | Breast Carcinoma Appropriate Neoadjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205188
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [3,4]
C0474926
UMLS CUI [4,1]
C0853879
UMLS CUI [4,2]
C0333348
UMLS CUI [4,3]
C0474926
UMLS CUI [5,1]
C0678222
UMLS CUI [5,2]
C1548787
UMLS CUI [5,3]
C0600558
UMLS CUI [5,4]
C3665472
2. her2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (fish)
Beskrivning

Tumor HER2 Negative Immunohistochemistry | Tumor HER2 Negative FISH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348908
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2348908
UMLS CUI [2,3]
C0162789
3. ecog performance status 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. gender: female
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
5. age : >= 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. negative pregnancy test (females of childbearing potential)
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
7. willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential)
Beskrivning

Childbearing Potential Barrier Contraception Double

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0205173
8. signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. metastatic or relapsed disease
Beskrivning

Neoplasm Metastasis | Recurrent disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0277556
2. major surgery < 3 weeks prior to enrollment
Beskrivning

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
3. severe pulmonary obstructive or restrictive disease
Beskrivning

Obstructive Lung Diseases Severe | Restrictive pulmonary disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600260
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0877013
UMLS CUI [2,2]
C0205082
4. uncontrolled inflammatory disease (autoimmune or infectious)
Beskrivning

Inflammatory disorder Uncontrolled | Autoimmune Disease Uncontrolled | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
5. clinically significant cardiac disease (nyha stadium > 2)
Beskrivning

Heart Disease New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
6. results of laboratory tests (hematology, chemistry) outside specified limits:
Beskrivning

Laboratory test result abnormal | Hematology procedure | Chemistry procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0200627
UMLS CUI [3]
C0201682
wbc ≤ 3 x 109/l
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
anc < 1.5 x 109/l
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets < 100 x 109/l
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
ptt/ inr > 1.5 x uln
Beskrivning

Partial thromboplastin time increased | INR raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0240671
UMLS CUI [2]
C0853225
ast or alt > 2.5 x uln
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
alkaline phosphatase > 2 x uln
Beskrivning

Serum alkaline phosphatase raised

Datatyp

boolean

Alias
UMLS CUI [1]
C1314665
total bilirubin > 1.5 x uln
Beskrivning

Elevated total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
7. pregnancy or nursing status
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. known positive hiv testing
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
9. known hypersensitivity to any component of the endotag-1, paclitaxel or fec formulations
Beskrivning

Hypersensitivity EndoTAG-1 Component | Hypersensitivity Paclitaxel Component | Hypersensitivity FEC Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2347570
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0144576
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0060133
UMLS CUI [3,3]
C1705248
10. history of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
Beskrivning

Malignant Neoplasms | Exception Breast Carcinoma | Exception Local Therapy Skin carcinoma | Exception Local Therapy Basal cell carcinoma | Exception Local Therapy Squamous cell carcinoma of skin

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]
C1517925
UMLS CUI [3,3]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1517925
UMLS CUI [4,3]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1517925
UMLS CUI [5,3]
C0553723
11. history of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
Beskrivning

Nervous system disorder Preventing Informed Consent | Mental disorder Preventing Informed Consent | Nervous system disorder Interferes with Evaluation Central Nervous System | Mental disorder Interferes with Evaluation Central Nervous System

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C3714787
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C3714787
12. concurrent treatment with other experimental products. participation in another clinical trial with any investigational product within 30 days prior to study entry
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Breast Cancer NCT01537536

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Invasive carcinoma of breast Operable TNM Breast tumor staging | Invasive carcinoma of breast Advanced Locally TNM Breast tumor staging | Invasive carcinoma of breast inflammatory TNM Breast tumor staging | Breast Carcinoma Appropriate Neoadjuvant Chemotherapy
Item
1. newly diagnosed histologically confirmed bc with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
boolean
C0678222 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0474926 (UMLS CUI [3,4])
C0853879 (UMLS CUI [4,1])
C0333348 (UMLS CUI [4,2])
C0474926 (UMLS CUI [4,3])
C0678222 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C0600558 (UMLS CUI [5,3])
C3665472 (UMLS CUI [5,4])
Tumor HER2 Negative Immunohistochemistry | Tumor HER2 Negative FISH
Item
2. her2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (fish)
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
ECOG performance status
Item
3. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Gender
Item
4. gender: female
boolean
C0079399 (UMLS CUI [1])
Age
Item
5. age : >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
6. negative pregnancy test (females of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Barrier Contraception Double
Item
7. willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
Informed Consent
Item
8. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis | Recurrent disease
Item
1. metastatic or relapsed disease
boolean
C0027627 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Major surgery
Item
2. major surgery < 3 weeks prior to enrollment
boolean
C0679637 (UMLS CUI [1])
Obstructive Lung Diseases Severe | Restrictive pulmonary disease Severe
Item
3. severe pulmonary obstructive or restrictive disease
boolean
C0600260 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0877013 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Inflammatory disorder Uncontrolled | Autoimmune Disease Uncontrolled | Communicable Disease Uncontrolled
Item
4. uncontrolled inflammatory disease (autoimmune or infectious)
boolean
C1290884 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Heart Disease New York Heart Association Classification
Item
5. clinically significant cardiac disease (nyha stadium > 2)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Laboratory test result abnormal | Hematology procedure | Chemistry procedure
Item
6. results of laboratory tests (hematology, chemistry) outside specified limits:
boolean
C0438215 (UMLS CUI [1])
C0200627 (UMLS CUI [2])
C0201682 (UMLS CUI [3])
White Blood Cell Count procedure
Item
wbc ≤ 3 x 109/l
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
anc < 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets < 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
boolean
C0518015 (UMLS CUI [1])
Partial thromboplastin time increased | INR raised
Item
ptt/ inr > 1.5 x uln
boolean
C0240671 (UMLS CUI [1])
C0853225 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast or alt > 2.5 x uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum alkaline phosphatase raised
Item
alkaline phosphatase > 2 x uln
boolean
C1314665 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin > 1.5 x uln
boolean
C0741494 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
7. pregnancy or nursing status
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
8. known positive hiv testing
boolean
C0019699 (UMLS CUI [1])
Hypersensitivity EndoTAG-1 Component | Hypersensitivity Paclitaxel Component | Hypersensitivity FEC Component
Item
9. known hypersensitivity to any component of the endotag-1, paclitaxel or fec formulations
boolean
C0020517 (UMLS CUI [1,1])
C2347570 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0060133 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Local Therapy Skin carcinoma | Exception Local Therapy Basal cell carcinoma | Exception Local Therapy Squamous cell carcinoma of skin
Item
10. history of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1517925 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1517925 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1517925 (UMLS CUI [5,2])
C0553723 (UMLS CUI [5,3])
Nervous system disorder Preventing Informed Consent | Mental disorder Preventing Informed Consent | Nervous system disorder Interferes with Evaluation Central Nervous System | Mental disorder Interferes with Evaluation Central Nervous System
Item
11. history of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
boolean
C0027765 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C3714787 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C3714787 (UMLS CUI [4,4])
Study Subject Participation Status | Investigational New Drugs
Item
12. concurrent treatment with other experimental products. participation in another clinical trial with any investigational product within 30 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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