ID

40815

Descripción

Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01855828

Link

https://clinicaltrials.gov/show/NCT01855828

Palabras clave

Versiones (1)
  1. 18/5/20 18/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Her2-Positive Breast Cancer NCT01855828

Inglés

Eligibility Her2-Positive Breast Cancer NCT01855828

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed stage i-iii, her2-positive invasive breast cancer for which adjuvant/neoadjuvant chemotherapy is indicated based on physician judgment following nccn practice guidelines.
Descripción

Invasive carcinoma of breast HER2 Positive TNM Breast tumor staging | Indication Adjuvant Chemotherapy | Indication Neoadjuvant Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0085533
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C3665472
her2 overexpression or amplification will be based on local test results and is defined as either:
Descripción

HER2 Overexpression Test result | HER2 gene amplification Test result

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0587081
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0587081
(i) ihc staining of 3+ (uniform, intense membrane staining) in greater than or equal to 10% of invasive tumor cells or, (ii) fluorescent in situ hybridization (fish) result of more than six her2 gene copies per nucleus or, (iii) fish ratio (her2 gene signals to chromosome 17 signals) of greater than or equal to 2.0.
Descripción

Malignant tumor cells Immunohistochemistry | HER2 Gene Dosage FISH | HER2/CEP17 Ratio FISH

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0334227
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0242957
UMLS CUI [2,2]
C0178655
UMLS CUI [2,3]
C0162789
UMLS CUI [3]
C1977461
patients with synchronous bilateral breast cancers are eligible if at least one of the tumors is her2-positive.
Descripción

Bilateral breast cancer Synchronous | Tumor Quantity HER2 Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0439580
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C2348909
left ventricular ejection fraction (lvef) greater or equal to 50% at baseline as determined by either echo or muga, or within the institution's normal limits.
Descripción

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
women of childbearing potential must have a negative pregnancy test (serum or urine beta hcg) prior to initiation of chemotherapy. both female and male breast cancer patients who are sexually active have to agree to practice contraception while participating in the trial and for 3 month after completion of therapy.
Descripción

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test beta-hCG Negative | Gender Sexually active Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [2,3]
C0106132
UMLS CUI [2,4]
C1513916
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
adequate bone marrow function as indicated by the following:
Descripción

Bone Marrow function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
anc greater than or equal to 1500/ul
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelets greater than or equal to 100,000/ul
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin greater than or equal to 10 g/dl
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
adequate renal function, as indicated by creatinine less than or equal to 1.5 times upper limit of normal (uln)
Descripción

Renal function | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate liver function, as indicated by bilirubin less than or equal to 1.5 x uln and ast or alt less than or equal to 2x uln.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
signed informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Exclusion Criteria Any Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
patients who underwent partial excisional biopsy, lumpectomy, segmental mastectomy, modified radical mastectomy or sentinel node biopsy and, therefore cannot be assessed for pathologic response accurately.
Descripción

Excision biopsy Partial | Lumpectomy of breast | Segmental Mastectomy | Modified radical mastectomy | Sentinel Lymph Node Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184921
UMLS CUI [1,2]
C0728938
UMLS CUI [2]
C0851238
UMLS CUI [3]
C0024885
UMLS CUI [4]
C0024883
UMLS CUI [5]
C0796693
patients who are high risk for developing the following anthracycline, paclitaxel, trastuzumab or pertuzumab related toxicities including:
Descripción

High risk Toxicity Anthracycline Related | High risk Toxicity Paclitaxel Related | High risk Toxicity Trastuzumab Related | High riskToxicity Pertuzumab Related

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C0282564
UMLS CUI [1,4]
C0439849
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C0600688
UMLS CUI [2,3]
C0144576
UMLS CUI [2,4]
C0439849
UMLS CUI [3,1]
C4319571
UMLS CUI [3,2]
C0600688
UMLS CUI [3,3]
C0728747
UMLS CUI [3,4]
C0439849
UMLS CUI [4,1]
C4319571
UMLS CUI [4,2]
C0600688
UMLS CUI [4,3]
C1328025
UMLS CUI [4,4]
C0439849
history of congestive heart failure, myocardial infarction or cardiomyopathy, uncontrolled hypertension despite adequate medications pre-existing peripheral neuropathy > grade 3 prior anthracycline therapy known hypersensitivity to any of the study medications patients older than age 65 due to increased risk of cardiotoxicity
Descripción

Congestive heart failure | Myocardial Infarction | Cardiomyopathy | Uncontrolled hypertension | Peripheral Neuropathy Pre-existing CTCAE Grades | Hypersensitivity Investigational New Drugs | Age | High risk Cardiotoxicity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0878544
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C0031117
UMLS CUI [5,2]
C2347662
UMLS CUI [5,3]
C1516728
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0013230
UMLS CUI [7]
C0001779
UMLS CUI [8,1]
C4319571
UMLS CUI [8,2]
C0876994
active infection requiring systemic antibiotic therapy.
Descripción

Communicable Disease | Requirement Antibiotic therapy Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0338237
UMLS CUI [2,3]
C0205373
pregnant or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Her2-Positive Breast Cancer NCT01855828

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast HER2 Positive TNM Breast tumor staging | Indication Adjuvant Chemotherapy | Indication Neoadjuvant Chemotherapy
Item
patients with histologically confirmed stage i-iii, her2-positive invasive breast cancer for which adjuvant/neoadjuvant chemotherapy is indicated based on physician judgment following nccn practice guidelines.
boolean
C0853879 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C3665472 (UMLS CUI [3,3])
HER2 Overexpression Test result | HER2 gene amplification Test result
Item
her2 overexpression or amplification will be based on local test results and is defined as either:
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C1512127 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
Malignant tumor cells Immunohistochemistry | HER2 Gene Dosage FISH | HER2/CEP17 Ratio FISH
Item
(i) ihc staining of 3+ (uniform, intense membrane staining) in greater than or equal to 10% of invasive tumor cells or, (ii) fluorescent in situ hybridization (fish) result of more than six her2 gene copies per nucleus or, (iii) fish ratio (her2 gene signals to chromosome 17 signals) of greater than or equal to 2.0.
boolean
C0334227 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0242957 (UMLS CUI [2,1])
C0178655 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C1977461 (UMLS CUI [3])
Bilateral breast cancer Synchronous | Tumor Quantity HER2 Positive
Item
patients with synchronous bilateral breast cancers are eligible if at least one of the tumors is her2-positive.
boolean
C0281267 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2348909 (UMLS CUI [2,3])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
left ventricular ejection fraction (lvef) greater or equal to 50% at baseline as determined by either echo or muga, or within the institution's normal limits.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test beta-hCG Negative | Gender Sexually active Contraceptive methods
Item
women of childbearing potential must have a negative pregnancy test (serum or urine beta hcg) prior to initiation of chemotherapy. both female and male breast cancer patients who are sexually active have to agree to practice contraception while participating in the trial and for 3 month after completion of therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C0106132 (UMLS CUI [2,3])
C1513916 (UMLS CUI [2,4])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Bone Marrow function
Item
adequate bone marrow function as indicated by the following:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Absolute neutrophil count
Item
anc greater than or equal to 1500/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets greater than or equal to 100,000/ul
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin greater than or equal to 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
adequate renal function, as indicated by creatinine less than or equal to 1.5 times upper limit of normal (uln)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate liver function, as indicated by bilirubin less than or equal to 1.5 x uln and ast or alt less than or equal to 2x uln.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any Fulfill
Item
patients will be excluded from the study based on any of the following criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Excision biopsy Partial | Lumpectomy of breast | Segmental Mastectomy | Modified radical mastectomy | Sentinel Lymph Node Biopsy
Item
patients who underwent partial excisional biopsy, lumpectomy, segmental mastectomy, modified radical mastectomy or sentinel node biopsy and, therefore cannot be assessed for pathologic response accurately.
boolean
C0184921 (UMLS CUI [1,1])
C0728938 (UMLS CUI [1,2])
C0851238 (UMLS CUI [2])
C0024885 (UMLS CUI [3])
C0024883 (UMLS CUI [4])
C0796693 (UMLS CUI [5])
High risk Toxicity Anthracycline Related | High risk Toxicity Paclitaxel Related | High risk Toxicity Trastuzumab Related | High riskToxicity Pertuzumab Related
Item
patients who are high risk for developing the following anthracycline, paclitaxel, trastuzumab or pertuzumab related toxicities including:
boolean
C4319571 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C0282564 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C4319571 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C0144576 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C4319571 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C0728747 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C4319571 (UMLS CUI [4,1])
C0600688 (UMLS CUI [4,2])
C1328025 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Congestive heart failure | Myocardial Infarction | Cardiomyopathy | Uncontrolled hypertension | Peripheral Neuropathy Pre-existing CTCAE Grades | Hypersensitivity Investigational New Drugs | Age | High risk Cardiotoxicity
Item
history of congestive heart failure, myocardial infarction or cardiomyopathy, uncontrolled hypertension despite adequate medications pre-existing peripheral neuropathy > grade 3 prior anthracycline therapy known hypersensitivity to any of the study medications patients older than age 65 due to increased risk of cardiotoxicity
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0878544 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0031117 (UMLS CUI [5,1])
C2347662 (UMLS CUI [5,2])
C1516728 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C0001779 (UMLS CUI [7])
C4319571 (UMLS CUI [8,1])
C0876994 (UMLS CUI [8,2])
Communicable Disease | Requirement Antibiotic therapy Systemic
Item
active infection requiring systemic antibiotic therapy.
boolean
C0009450 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0338237 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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