ID

36075

Beschrijving

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

Trefwoorden

Versies (1)
  1. 14-04-19 14-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 april 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility HER-2 Positive Breast Cancer NCT02492711

Engels

Eligibility HER-2 Positive Breast Cancer NCT02492711

1 Formulieren  
Inclusion Criteria
Beschrijving

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Prior Therapy Quantity Metastatic Setting | Disease Progression

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
acceptable laboratory parameters
Beschrijving

Laboratory Results Acceptable

Datatype

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
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
known, untreated brain metastasis
Beschrijving

Metastatic malignant neoplasm to brain Untreated

Datatype

boolean

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

Seizures Uncontrolled

Datatype

boolean

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

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

Datatype

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
Beschrijving

Cardiovascular Disease

Datatype

boolean

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

Pulmonary function impairment | Requirement Supplemental oxygen

Datatype

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
Beschrijving

Medical contraindication Trastuzumab | Condition Preventing Chemotherapy

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility HER-2 Positive Breast Cancer NCT02492711

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial