ID

26859

Description

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

Keywords

Versions (1)
  1. 10/26/17 10/26/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00934856

English

Eligibility Breast Cancer NCT00934856

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Age

Data type

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)
Description

ECOG performance status | ECOG performance status Due to Bone Diseases

Data type

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
Description

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

Data type

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:
Description

Patients Secondary malignant neoplasm of female breast

Data type

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
Description

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

Data type

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
Description

Disease Progression

Data type

boolean

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

Patients Locally advanced breast cancer

Data type

boolean

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

Locally advanced breast cancer Newly Diagnosed TNM Breast tumor staging

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Heart Disease

Data type

boolean

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

Bone Marrow function Inadequate | Liver Dysfunction | Abnormal renal function

Data type

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:
Description

Patients Secondary malignant neoplasm of female breast

Data type

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
Description

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

Data type

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
Description

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

Data type

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:
Description

Patients Locally advanced breast cancer

Data type

boolean

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

Neoplasm Metastasis Detectable

Data type

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
Description

Operative Surgical Procedures Intent Primary

Data type

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
Description

Cancer treatment Systemic | Cancer treatment Local-Regional

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1947913
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Similar models

Eligibility Breast Cancer NCT00934856

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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