ID

37778

Beschreibung

Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01036087

Link

https://clinicaltrials.gov/show/NCT01036087

Stichworte

Versionen (2)
  1. 23.08.19 23.08.19 -
  2. 24.08.19 24.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. August 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01036087

Englisch

Eligibility Breast Cancer NCT01036087

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological confirmation of breast carcinoma. pathologic evidence of dermal lymphatic invasion should be noted but not required.
Beschreibung

Breast Carcinoma | Lymphatic Invasion Dermal

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C1708790
UMLS CUI [2,2]
C0221928
2. clinical diagnosis of ibc (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
Beschreibung

Inflammatory Breast Carcinoma | Breast changes inflammatory | Erythema diffuse | Heat | Ridging | Peau d'orange

Datentyp

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2,1]
C0558236
UMLS CUI [2,2]
C0333348
UMLS CUI [3]
C0858689
UMLS CUI [4]
C0018837
UMLS CUI [5]
C0332243
UMLS CUI [6]
C0425791
3. >/= age 18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status </= 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. adequate hematologic function: absolute neutrophil count (anc) >/= 1.5 x 109/l, platelet count >/= 100 x 109/l, hemoglobin >/= 9.0 g/dl
Beschreibung

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
6. adequate cardiac function (lvef >/= 45%)
Beschreibung

Cardiac function | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
7. adequate renal function: creatinine (cr) </= 1.5 mg/dl x uln, creatinine clearance (crcl) >/= 50 ml/min calculated by the cockcroft-gault method as follows: male creatinine clearance = (140 - age) x (weight in kg) / (serum cr x 72) female crcl = (140 - age) x (weight in kg) x 0.85 / (serum cr x 72)
Beschreibung

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
8. adequate hepatic function: aspartate aminotransferase (ast) </= 2.5 x uln • alanine aminotransferase (alt) </= 2.5 x uln • alkaline phosphatase (alp) </= 2.5 x uln.total bilirubin </=1.5 x uln
Beschreibung

Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C1278039
9. ability and willingness to sign an informed consent form for this protocol
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
10. if female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (iud) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide.
Beschreibung

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Partner Male sterilization | Intrauterine Devices | Oral contraception | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condom | Vaginal Spermicide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0024559
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0029151
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0087145
11. patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible,
Beschreibung

Neoplasm Metastasis | Local Therapy Site metastatic | Therapeutic radiology procedure | Operative Surgical Procedure | Patients Appropriate Operation on breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1517925
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C1522484
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0543467
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1548787
UMLS CUI [5,3]
C3714726
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of radiation or chemotherapy
Beschreibung

Therapeutic radiology procedure | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
2. her2-positive breast carcinoma (ihc staining more than 3+ or her2 gene amplification by fish)
Beschreibung

HER2-positive carcinoma of breast Immunohistochemistry Staining Method | HER2 gene amplification FISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0162789
3. recurrent breast cancer
Beschreibung

Breast cancer recurrent

Datentyp

boolean

Alias
UMLS CUI [1]
C0278493
4. history of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for >5 years)
Beschreibung

Cancer Other | Exception Skin carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured | Exception Disease Free Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
UMLS CUI [4,4]
C0449238
5. known positive test(s) for human immunodeficiency virus infection, hepatitis c virus, acute or chronic active hepatitis b infection
Beschreibung

HIV Seropositivity | Hepatitis C positive | Hepatitis B positive | Hepatitis B, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0856706
UMLS CUI [4]
C0524909
6. history of extensive interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest ct scan
Beschreibung

Interstitial Lung Disease Extensive | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Extensive Chest CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C0205231
UMLS CUI [2]
C3714636
UMLS CUI [3]
C0034069
UMLS CUI [4,1]
C0206062
UMLS CUI [4,2]
C0205231
UMLS CUI [4,3]
C0202823
7. patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.
Beschreibung

Medical condition Difficulty with Assessment Toxicity | Mental condition Difficulty with Assessment Toxicity | Medical condition Difficulty with Assessment Effectiveness | Mental condition Difficulty with Assessment Effectiveness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332218
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0600688
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0332218
UMLS CUI [2,3]
C1516048
UMLS CUI [2,4]
C0600688
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332218
UMLS CUI [3,3]
C1516048
UMLS CUI [3,4]
C1280519
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0332218
UMLS CUI [4,3]
C1516048
UMLS CUI [4,4]
C1280519
8. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Beschreibung

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
9. peripheral neuropathy >= gr ii
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
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Ähnliche Modelle

Eligibility Breast Cancer NCT01036087

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Lymphatic Invasion Dermal
Item
1. histological confirmation of breast carcinoma. pathologic evidence of dermal lymphatic invasion should be noted but not required.
boolean
C0678222 (UMLS CUI [1])
C1708790 (UMLS CUI [2,1])
C0221928 (UMLS CUI [2,2])
Inflammatory Breast Carcinoma | Breast changes inflammatory | Erythema diffuse | Heat | Ridging | Peau d'orange
Item
2. clinical diagnosis of ibc (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
boolean
C0278601 (UMLS CUI [1])
C0558236 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
C0858689 (UMLS CUI [3])
C0018837 (UMLS CUI [4])
C0332243 (UMLS CUI [5])
C0425791 (UMLS CUI [6])
Age
Item
3. >/= age 18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status </= 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
5. adequate hematologic function: absolute neutrophil count (anc) >/= 1.5 x 109/l, platelet count >/= 100 x 109/l, hemoglobin >/= 9.0 g/dl
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Cardiac function | Left ventricular ejection fraction
Item
6. adequate cardiac function (lvef >/= 45%)
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
7. adequate renal function: creatinine (cr) </= 1.5 mg/dl x uln, creatinine clearance (crcl) >/= 50 ml/min calculated by the cockcroft-gault method as follows: male creatinine clearance = (140 - age) x (weight in kg) / (serum cr x 72) female crcl = (140 - age) x (weight in kg) x 0.85 / (serum cr x 72)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement
Item
8. adequate hepatic function: aspartate aminotransferase (ast) </= 2.5 x uln • alanine aminotransferase (alt) </= 2.5 x uln • alkaline phosphatase (alp) </= 2.5 x uln.total bilirubin </=1.5 x uln
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Informed Consent
Item
9. ability and willingness to sign an informed consent form for this protocol
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Partner Male sterilization | Intrauterine Devices | Oral contraception | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condom | Vaginal Spermicide
Item
10. if female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (iud) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C0024559 (UMLS CUI [3,2])
C0021900 (UMLS CUI [4])
C0029151 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
Neoplasm Metastasis | Local Therapy Site metastatic | Therapeutic radiology procedure | Operative Surgical Procedure | Patients Appropriate Operation on breast
Item
11. patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible,
boolean
C0027627 (UMLS CUI [1])
C1517925 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C3714726 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Chemotherapy
Item
1. history of radiation or chemotherapy
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
HER2-positive carcinoma of breast Immunohistochemistry Staining Method | HER2 gene amplification FISH
Item
2. her2-positive breast carcinoma (ihc staining more than 3+ or her2 gene amplification by fish)
boolean
C1960398 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Breast cancer recurrent
Item
3. recurrent breast cancer
boolean
C0278493 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured | Exception Disease Free Duration
Item
4. history of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for >5 years)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
HIV Seropositivity | Hepatitis C positive | Hepatitis B positive | Hepatitis B, Chronic
Item
5. known positive test(s) for human immunodeficiency virus infection, hepatitis c virus, acute or chronic active hepatitis b infection
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0856706 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
Interstitial Lung Disease Extensive | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Extensive Chest CT scan
Item
6. history of extensive interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest ct scan
boolean
C0206062 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C3714636 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
C0206062 (UMLS CUI [4,1])
C0205231 (UMLS CUI [4,2])
C0202823 (UMLS CUI [4,3])
Medical condition Difficulty with Assessment Toxicity | Mental condition Difficulty with Assessment Toxicity | Medical condition Difficulty with Assessment Effectiveness | Mental condition Difficulty with Assessment Effectiveness
Item
7. patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.
boolean
C3843040 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0332218 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C1280519 (UMLS CUI [3,4])
C3840291 (UMLS CUI [4,1])
C0332218 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
C1280519 (UMLS CUI [4,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Peripheral Neuropathy CTCAE Grades
Item
9. peripheral neuropathy >= gr ii
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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