ID

36075

Descrição

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02492711

Link

https://clinicaltrials.gov/show/NCT02492711

Palavras-chave

Versões (1)
  1. 14/04/2019 14/04/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility HER-2 Positive Breast Cancer NCT02492711

Inglês

Eligibility HER-2 Positive Breast Cancer NCT02492711

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically-proven metastatic or locally-advanced relapsed/refractory her2+ breast cancer. tumors may be estrogen receptor (er)/progesterone receptor (pr) positive or negative.
Descrição

BREAST CANCER METASTATIC RECURRENT HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive Refractory | Locally advanced breast cancer HER2 Positive Relapsed | Locally advanced breast cancer HER2 Positive Refractory | Estrogen receptor positive tumor | Progesterone receptor positive tumor | Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0741681
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C2348909
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C3495949
UMLS CUI [3,2]
C2348909
UMLS CUI [3,3]
C0205336
UMLS CUI [4,1]
C3495949
UMLS CUI [4,2]
C2348909
UMLS CUI [4,3]
C0205269
UMLS CUI [5]
C1562312
UMLS CUI [6]
C1562928
UMLS CUI [7]
C2584629
UMLS CUI [8]
C2584628
prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. prior radiotherapy and hormonal therapies are allowed.
Descrição

pertuzumab | trastuzumab | ado-trastuzumab emtansine | Neoadjuvant Setting | Adjuvant Setting | Metastatic Setting | Prior radiation therapy | Prior Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1328025
UMLS CUI [2]
C0728747
UMLS CUI [3]
C2935436
UMLS CUI [4]
C4086621
UMLS CUI [5]
C4084850
UMLS CUI [6]
C4085632
UMLS CUI [7]
C0279134
UMLS CUI [8]
C1514460
prior treatment for at least one, and no more than two, lines of therapy in the metastatic setting. patients must have progressed on or following, the most recent line of therapy.
Descrição

Prior Therapy Quantity Metastatic Setting | Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C4085632
UMLS CUI [2]
C0242656
resolution of all chemotherapy or radiation-related toxicities to ≤ grade 1
Descrição

Toxicity Due to Chemotherapy | Toxicity due to radiotherapy | Resolution CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0392920
UMLS CUI [2]
C1302210
UMLS CUI [3,1]
C1514893
UMLS CUI [3,2]
C1516728
life expectancy ≥ 12 weeks
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
acceptable laboratory parameters
Descrição

Laboratory Results Acceptable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
women of childbearing potential must have negative pregnancy test, and agree to use an effective form of contraception for the duration of study treatment and for 120 days after the last dose of study drug
Descrição

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known, untreated brain metastasis
Descrição

Metastatic malignant neoplasm to brain Untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
history of uncontrolled seizures
Descrição

Seizures Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
prior allogeneic bone marrow, stem-cell, or solid organ transplantation
Descrição

Allogeneic bone marrow transplantation | Allogeneic Stem Cell Transplantation | Solid organ transplant Allogeneic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C2242529
UMLS CUI [3,1]
C0730400
UMLS CUI [3,2]
C1515895
history of clinically significant cardiovascular disease
Descrição

Cardiovascular Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use
Descrição

Pulmonary function impairment | Requirement Supplemental oxygen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0858943
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C4534306
any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the protocol specified chemotherapies
Descrição

Medical contraindication Trastuzumab | Condition Preventing Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0392920
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Similar models

Eligibility HER-2 Positive Breast Cancer NCT02492711

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
BREAST CANCER METASTATIC RECURRENT HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive Refractory | Locally advanced breast cancer HER2 Positive Relapsed | Locally advanced breast cancer HER2 Positive Refractory | Estrogen receptor positive tumor | Progesterone receptor positive tumor | Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm
Item
histologically-proven metastatic or locally-advanced relapsed/refractory her2+ breast cancer. tumors may be estrogen receptor (er)/progesterone receptor (pr) positive or negative.
boolean
C0741681 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C3495949 (UMLS CUI [3,1])
C2348909 (UMLS CUI [3,2])
C0205336 (UMLS CUI [3,3])
C3495949 (UMLS CUI [4,1])
C2348909 (UMLS CUI [4,2])
C0205269 (UMLS CUI [4,3])
C1562312 (UMLS CUI [5])
C1562928 (UMLS CUI [6])
C2584629 (UMLS CUI [7])
C2584628 (UMLS CUI [8])
pertuzumab | trastuzumab | ado-trastuzumab emtansine | Neoadjuvant Setting | Adjuvant Setting | Metastatic Setting | Prior radiation therapy | Prior Hormone Therapy
Item
prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. prior radiotherapy and hormonal therapies are allowed.
boolean
C1328025 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C2935436 (UMLS CUI [3])
C4086621 (UMLS CUI [4])
C4084850 (UMLS CUI [5])
C4085632 (UMLS CUI [6])
C0279134 (UMLS CUI [7])
C1514460 (UMLS CUI [8])
Prior Therapy Quantity Metastatic Setting | Disease Progression
Item
prior treatment for at least one, and no more than two, lines of therapy in the metastatic setting. patients must have progressed on or following, the most recent line of therapy.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4085632 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Toxicity Due to Chemotherapy | Toxicity due to radiotherapy | Resolution CTCAE Grades
Item
resolution of all chemotherapy or radiation-related toxicities to ≤ grade 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1302210 (UMLS CUI [2])
C1514893 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
Laboratory Results Acceptable
Item
acceptable laboratory parameters
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of childbearing potential must have negative pregnancy test, and agree to use an effective form of contraception for the duration of study treatment and for 120 days after the last dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Untreated
Item
known, untreated brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Seizures Uncontrolled
Item
history of uncontrolled seizures
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Allogeneic bone marrow transplantation | Allogeneic Stem Cell Transplantation | Solid organ transplant Allogeneic
Item
prior allogeneic bone marrow, stem-cell, or solid organ transplantation
boolean
C0149615 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
C0730400 (UMLS CUI [3,1])
C1515895 (UMLS CUI [3,2])
Cardiovascular Disease
Item
history of clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Pulmonary function impairment | Requirement Supplemental oxygen
Item
clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use
boolean
C0858943 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C4534306 (UMLS CUI [2,2])
Medical contraindication Trastuzumab | Condition Preventing Chemotherapy
Item
any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the protocol specified chemotherapies
boolean
C1301624 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
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