ID

26859

Beschrijving

A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00934856

Link

https://clinicaltrials.gov/show/NCT00934856

Trefwoorden

Versies (1)
  1. 26-10-17 26-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

26 oktober 2017

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 Breast Cancer NCT00934856

Engels

Eligibility Breast Cancer NCT00934856

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
ecog performance status 0-1 (ecog performance status of 2 will be allowed if only due to debilitating bone disease)
Beschrijving

ECOG performance status | ECOG performance status Due to Bone Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C1520224
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0005940
her2-positive metastatic or locally advanced breast cancer
Beschrijving

Secondary malignant neoplasm of female breast HER2/Neu Positive | Locally advanced breast cancer HER2/Neu Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C2348909
for mbc (metastatic breast cancer) patients:
Beschrijving

Patients Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0346993
documented metastatic or inoperable locally advanced (without meeting labc criteria) disease, amenable for treatment with docetaxel
Beschrijving

Secondary malignant neoplasm of female breast | Locally advanced breast cancer Inoperable | Docetaxel

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C0205187
UMLS CUI [3]
C0246415
history of disease progression within 3 months prior to study entry
Beschrijving

Disease Progression

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
for labc (locally advanced breast cancer) patients:
Beschrijving

Patients Locally advanced breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3495949
newly diagnosed locally advanced breast cancer, stage iiia-iiic (ajcc staging system)
Beschrijving

Locally advanced breast cancer Newly Diagnosed TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C1518321
UMLS CUI [1,3]
C0474926
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant cardiac disease
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
inadequate bone marrow, liver or renal function
Beschrijving

Bone Marrow function Inadequate | Liver Dysfunction | Abnormal renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0151746
for mbc patients:
Beschrijving

Patients Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0346993
patients must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases
Beschrijving

Therapeutic radiology procedure Secondary malignant neoplasm of female breast | Therapeutic radiology procedure Recurrent disease Local | Therapeutic radiology procedure Locally advanced breast cancer | Exception Pain relief | Bone lesion Metastatic Progressive | Exception Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0277556
UMLS CUI [2,3]
C0205276
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C3495949
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0451615
UMLS CUI [5,1]
C0238792
UMLS CUI [5,2]
C1522484
UMLS CUI [5,3]
C0205329
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0220650
brain metastases that are untreated, symptomatic or require therapy to control symptoms
Beschrijving

Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Treatment required Symptom control

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0332121
UMLS CUI [3,3]
C1274136
for labc patients:
Beschrijving

Patients Locally advanced breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3495949
clinically or radiologically detectable metastasis (m1 disease)
Beschrijving

Neoplasm Metastasis Detectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3830527
patients for whom surgery as primary intent procedure is the best option to treat their disease
Beschrijving

Operative Surgical Procedures Intent Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C0205225
previous systemic or loco regional anti-cancer therapy for locally advanced disease
Beschrijving

Cancer treatment Systemic | Cancer treatment Local-Regional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1947913
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00934856

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status | ECOG performance status Due to Bone Diseases
Item
ecog performance status 0-1 (ecog performance status of 2 will be allowed if only due to debilitating bone disease)
boolean
C1520224 (UMLS CUI [1])
C1520224 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0005940 (UMLS CUI [2,3])
Secondary malignant neoplasm of female breast HER2/Neu Positive | Locally advanced breast cancer HER2/Neu Positive
Item
her2-positive metastatic or locally advanced breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Patients Secondary malignant neoplasm of female breast
Item
for mbc (metastatic breast cancer) patients:
boolean
C0030705 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast | Locally advanced breast cancer Inoperable | Docetaxel
Item
documented metastatic or inoperable locally advanced (without meeting labc criteria) disease, amenable for treatment with docetaxel
boolean
C0346993 (UMLS CUI [1])
C3495949 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C0246415 (UMLS CUI [3])
Disease Progression
Item
history of disease progression within 3 months prior to study entry
boolean
C0242656 (UMLS CUI [1])
Patients Locally advanced breast cancer
Item
for labc (locally advanced breast cancer) patients:
boolean
C0030705 (UMLS CUI [1,1])
C3495949 (UMLS CUI [1,2])
Locally advanced breast cancer Newly Diagnosed TNM Breast tumor staging
Item
newly diagnosed locally advanced breast cancer, stage iiia-iiic (ajcc staging system)
boolean
C3495949 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease
Item
significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Bone Marrow function Inadequate | Liver Dysfunction | Abnormal renal function
Item
inadequate bone marrow, liver or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0086565 (UMLS CUI [2])
C0151746 (UMLS CUI [3])
Patients Secondary malignant neoplasm of female breast
Item
for mbc patients:
boolean
C0030705 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Therapeutic radiology procedure Secondary malignant neoplasm of female breast | Therapeutic radiology procedure Recurrent disease Local | Therapeutic radiology procedure Locally advanced breast cancer | Exception Pain relief | Bone lesion Metastatic Progressive | Exception Metastatic malignant neoplasm to brain
Item
patients must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases
boolean
C1522449 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C3495949 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0451615 (UMLS CUI [4,2])
C0238792 (UMLS CUI [5,1])
C1522484 (UMLS CUI [5,2])
C0205329 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0220650 (UMLS CUI [6,2])
Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Treatment required Symptom control
Item
brain metastases that are untreated, symptomatic or require therapy to control symptoms
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C1274136 (UMLS CUI [3,3])
Patients Locally advanced breast cancer
Item
for labc patients:
boolean
C0030705 (UMLS CUI [1,1])
C3495949 (UMLS CUI [1,2])
Neoplasm Metastasis Detectable
Item
clinically or radiologically detectable metastasis (m1 disease)
boolean
C0027627 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Operative Surgical Procedures Intent Primary
Item
patients for whom surgery as primary intent procedure is the best option to treat their disease
boolean
C0543467 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Cancer treatment Systemic | Cancer treatment Local-Regional
Item
previous systemic or loco regional anti-cancer therapy for locally advanced disease
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
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