ID

35086

Descrição

Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02229149

Link

https://clinicaltrials.gov/show/NCT02229149

Palavras-chave

Versões (1)
  1. 15/02/2019 15/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02229149

Inglês

Eligibility Breast Neoplasms NCT02229149

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female, age ≥ 18 years
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologic or cytologic confirmation of human epidermal growth factor receptor 2 (her2)-positive breast cancer according to most recent biopsy (local testing permitted)
Descrição

HER2-positive carcinoma of breast Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0005558
3. measurable or evaluable metastatic disease by response evaluation criteria in solid tumors (recist) (v1.1)
Descrição

Neoplasm Metastasis Measurable | Neoplasm Metastasis Evaluable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1516986
4. previous treatment with ado-trastuzumab emtansine (t-dm1) for metastatic disease
Descrição

Prior Therapy Neoplasm Metastasis | Ado-trastuzumab emtansine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C2935436
a. prior therapy with pertuzumab is allowed but not required
Descrição

Pertuzumab allowed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1328025
UMLS CUI [1,2]
C0683607
5. at least 1 but no more than 3 prior chemotherapy regimens for metastatic breast cancer (mbc)
Descrição

Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
6. life expectancy > 6 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
7. eastern cooperative group (ecog) performance status ≤ 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
8. left ventricular ejection fraction (lvef) ≥ 50% at baseline as determined by either echocardiogram (echo) or multi gated acquisition scan (muga) and within normal limits per institutional guidelines
Descrição

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
9. adequate bone marrow function as indicated by the following:
Descrição

Bone Marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
1. absolute neutrophil count (anc) ≥1500/ul (or 1500 per microliter)
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
2. platelets ≥100,000/ul
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
3. hemoglobin >9 g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
10. adequate renal function, as indicated by creatinine <1.5 times upper limit of normal (uln)
Descrição

Renal function | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
11. adequate liver function, as indicated by bilirubin <1.5 times uln
Descrição

Liver function | Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
12. aspartate aminotransferase (ast) and alanine aminotransferase (alt) <2 x uln unless liver metastases are present in which case ast and alt up to 5.x uln are allowed
Descrição

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
13. negative serum pregnancy test within 72 hours before starting study medications for women of childbearing potential
Descrição

Childbearing Potential Serum pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
14. women of childbearing potential must be willing to use an acceptable form of birth control (ie, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study note: women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or if they have undergone surgical sterilization.
Descrição

Childbearing Potential Contraceptive methods | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence | Postmenopausal state | Amenorrhea Duration | Profile Clinical Appropriate | Age | Vasomotor symptoms | Female Sterilization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0021900
UMLS CUI [3]
C0042241
UMLS CUI [4]
C0087145
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0036899
UMLS CUI [7]
C0232970
UMLS CUI [8,1]
C0002453
UMLS CUI [8,2]
C0449238
UMLS CUI [9,1]
C1979963
UMLS CUI [9,2]
C0205210
UMLS CUI [9,3]
C1548787
UMLS CUI [10]
C0001779
UMLS CUI [11]
C0750152
UMLS CUI [12]
C0015787
15. signed informed consent obtained prior to any screening procedures.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from the study based on the following criteria:
Descrição

Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. prior treatment in the metastatic setting with the agent chosen as physician's choice of chemotherapy
Descrição

Prior Therapy Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0027627
2. active infection
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
3. uncontrolled central nervous system metastases, defined as clinical or radiologic evidence of progression of brain metastases or clinical signs of leptomeningeal disease
Descrição

CNS metastases Uncontrolled | Metastatic malignant neoplasm to brain Progression | Sign or Symptom Leptomeningeal disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0242656
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0751297
a. patients with treated brain metastases are eligible provided they do not have clinical or radiologic evidence of disease progression and have been off of dexamethasone for at least 3 weeks
Descrição

Metastatic malignant neoplasm to brain Treated Eligible | Disease Progression Absent | Dexamethasone Discontinued

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C1548635
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0011777
UMLS CUI [3,2]
C1444662
4. patient is pregnant or lactating
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
Descrição

Prior Chemotherapy | Nitrosoureas | Mitomycin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0028210
UMLS CUI [3]
C0002475
6. prior radiation therapy within the last 2 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).
Descrição

Prior radiation therapy | Prior radiation therapy Lesion Involved

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C1314939
7. requirement for chronic steroid therapy with a requirement for > 5mg/day of prednisone or the equivalent.
Descrição

Patient need for Steroid therapy chronic | Patient need for Prednisone U/day | Patient need for Equivalent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0149783
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0205163
a. treatment with physiologic doses of hydrocortisone up to 20 mg daily (qd) is allowed.
Descrição

Hydrocortisone Dose U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020268
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
8. requirement for immunosuppressive therapy, such as those used to treat autoimmune disease.
Descrição

Patient need for Therapeutic immunosuppression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021079
9. concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Descrição

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
10. history of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
Descrição

Heart Disease | Cardiac risk factors | Cardiac Arrhythmia Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C2024776
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
11. ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower
Descrição

Cardiac ejection fraction | Decreased cardiac ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C3661817
12. known hypersensitivity to trastuzumab or pertuzumab
Descrição

Hypersensitivity Trastuzumab | Hypersensitivity Pertuzumab

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1328025
13. serious medical or psychiatric limitations likely to interfere with participation in this study.
Descrição

Impairment Serious Interferes with Study Subject Participation Status | Mental handicap Serious Interferes with Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221099
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C1306341
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
14. symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest or requiring supplemental oxygen
Descrição

Lung disease Intrinsic Symptomatic | Neoplasm Involvement Extensive Lung | Resting Dyspnea | Patient need for Supplemental oxygen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205102
UMLS CUI [1,3]
C0231220
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0205231
UMLS CUI [2,4]
C0024109
UMLS CUI [3]
C0743330
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C4534306
15. patient is currently part of or has participated in any clinical trial of an investigational agent within 1 month prior to enrollment in this study.
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Eligibility Breast Neoplasms NCT02229149

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female, age ≥ 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2-positive carcinoma of breast Biopsy
Item
2. histologic or cytologic confirmation of human epidermal growth factor receptor 2 (her2)-positive breast cancer according to most recent biopsy (local testing permitted)
boolean
C1960398 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Neoplasm Metastasis Measurable | Neoplasm Metastasis Evaluable
Item
3. measurable or evaluable metastatic disease by response evaluation criteria in solid tumors (recist) (v1.1)
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
Prior Therapy Neoplasm Metastasis | Ado-trastuzumab emtansine
Item
4. previous treatment with ado-trastuzumab emtansine (t-dm1) for metastatic disease
boolean
C1514463 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C2935436 (UMLS CUI [2])
Pertuzumab allowed
Item
a. prior therapy with pertuzumab is allowed but not required
boolean
C1328025 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
5. at least 1 but no more than 3 prior chemotherapy regimens for metastatic breast cancer (mbc)
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Life Expectancy
Item
6. life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA
Item
8. left ventricular ejection fraction (lvef) ≥ 50% at baseline as determined by either echocardiogram (echo) or multi gated acquisition scan (muga) and within normal limits per institutional guidelines
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Bone Marrow function
Item
9. adequate bone marrow function as indicated by the following:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) ≥1500/ul (or 1500 per microliter)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelets ≥100,000/ul
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hemoglobin >9 g/dl
boolean
C0518015 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
10. adequate renal function, as indicated by creatinine <1.5 times upper limit of normal (uln)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement
Item
11. adequate liver function, as indicated by bilirubin <1.5 times uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
12. aspartate aminotransferase (ast) and alanine aminotransferase (alt) <2 x uln unless liver metastases are present in which case ast and alt up to 5.x uln are allowed
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test negative
Item
13. negative serum pregnancy test within 72 hours before starting study medications for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence | Postmenopausal state | Amenorrhea Duration | Profile Clinical Appropriate | Age | Vasomotor symptoms | Female Sterilization
Item
14. women of childbearing potential must be willing to use an acceptable form of birth control (ie, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study note: women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or if they have undergone surgical sterilization.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0021900 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C0087145 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C0232970 (UMLS CUI [7])
C0002453 (UMLS CUI [8,1])
C0449238 (UMLS CUI [8,2])
C1979963 (UMLS CUI [9,1])
C0205210 (UMLS CUI [9,2])
C1548787 (UMLS CUI [9,3])
C0001779 (UMLS CUI [10])
C0750152 (UMLS CUI [11])
C0015787 (UMLS CUI [12])
Informed Consent
Item
15. signed informed consent obtained prior to any screening procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be excluded from the study based on the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prior Therapy Neoplasm Metastasis
Item
1. prior treatment in the metastatic setting with the agent chosen as physician's choice of chemotherapy
boolean
C1514463 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Communicable Disease
Item
2. active infection
boolean
C0009450 (UMLS CUI [1])
CNS metastases Uncontrolled | Metastatic malignant neoplasm to brain Progression | Sign or Symptom Leptomeningeal disease
Item
3. uncontrolled central nervous system metastases, defined as clinical or radiologic evidence of progression of brain metastases or clinical signs of leptomeningeal disease
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
C3540840 (UMLS CUI [3,1])
C0751297 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Treated Eligible | Disease Progression Absent | Dexamethasone Discontinued
Item
a. patients with treated brain metastases are eligible provided they do not have clinical or radiologic evidence of disease progression and have been off of dexamethasone for at least 3 weeks
boolean
C0220650 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011777 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
4. patient is pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Chemotherapy | Nitrosoureas | Mitomycin
Item
5. prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
boolean
C1514457 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
C0002475 (UMLS CUI [3])
Prior radiation therapy | Prior radiation therapy Lesion Involved
Item
6. prior radiation therapy within the last 2 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).
boolean
C0279134 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
Patient need for Steroid therapy chronic | Patient need for Prednisone U/day | Patient need for Equivalent
Item
7. requirement for chronic steroid therapy with a requirement for > 5mg/day of prednisone or the equivalent.
boolean
C0686904 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
Hydrocortisone Dose U/day
Item
a. treatment with physiologic doses of hydrocortisone up to 20 mg daily (qd) is allowed.
boolean
C0020268 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Patient need for Therapeutic immunosuppression
Item
8. requirement for immunosuppressive therapy, such as those used to treat autoimmune disease.
boolean
C0686904 (UMLS CUI [1,1])
C0021079 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
9. concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Heart Disease | Cardiac risk factors | Cardiac Arrhythmia Uncontrolled
Item
10. history of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
boolean
C0018799 (UMLS CUI [1])
C2024776 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Cardiac ejection fraction | Decreased cardiac ejection fraction
Item
11. ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower
boolean
C0232174 (UMLS CUI [1])
C3661817 (UMLS CUI [2])
Hypersensitivity Trastuzumab | Hypersensitivity Pertuzumab
Item
12. known hypersensitivity to trastuzumab or pertuzumab
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1328025 (UMLS CUI [2,2])
Impairment Serious Interferes with Study Subject Participation Status | Mental handicap Serious Interferes with Study Subject Participation Status
Item
13. serious medical or psychiatric limitations likely to interfere with participation in this study.
boolean
C0221099 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1306341 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Lung disease Intrinsic Symptomatic | Neoplasm Involvement Extensive Lung | Resting Dyspnea | Patient need for Supplemental oxygen
Item
14. symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest or requiring supplemental oxygen
boolean
C0024115 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205231 (UMLS CUI [2,3])
C0024109 (UMLS CUI [2,4])
C0743330 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C4534306 (UMLS CUI [4,2])
Study Subject Participation Status | Investigational New Drugs
Item
15. patient is currently part of or has participated in any clinical trial of an investigational agent within 1 month prior to enrollment in this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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