ID

16300

Description

Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line; ODM derived from: https://clinicaltrials.gov/show/NCT00191854

Link

https://clinicaltrials.gov/show/NCT00191854

Keywords

  1. 7/10/16 7/10/16 -
Uploaded on

July 10, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00191854

Eligibility Breast Cancer NCT00191854

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with histological or cytological proven diagnosis of breast cancer
Description

woman with diagnosis of breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0678222
stage iv disease
Description

Tumor Stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
Description

Previous anthracycline based regimens

Data type

boolean

Alias
UMLS CUI [1]
C0278941
UMLS CUI [2]
C2939420
adequate organ function
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy for metastatic disease
Description

prior chemotherapy for metastatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C2939420
previous radiation therapy is allowed but must not have included whole pelvis radiation
Description

whole pelvis radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C3827467
known or suspected brain metastasis. serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
Description

brain metastasis or serious concomitant disorders

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0009488
concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (herceptin))
Description

concurrent tumor therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0920425
peripheral neuropathy of common toxicity criteria (ctc) grade greater than 1. history of significant neurological or mental disorder, including seizures or dementia
Description

peripheral neuropathy, neurological or mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0004936

Similar models

Eligibility Breast Cancer NCT00191854

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
woman with diagnosis of breast cancer
Item
female patients with histological or cytological proven diagnosis of breast cancer
boolean
C0079399 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Tumor Stage
Item
stage iv disease
boolean
C1300072 (UMLS CUI [1])
ECOG
Item
performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale
boolean
C1520224 (UMLS CUI [1])
Previous anthracycline based regimens
Item
patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
boolean
C0278941 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior chemotherapy for metastatic disease
Item
prior chemotherapy for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
whole pelvis radiation
Item
previous radiation therapy is allowed but must not have included whole pelvis radiation
boolean
C1522449 (UMLS CUI [1,1])
C3827467 (UMLS CUI [1,2])
brain metastasis or serious concomitant disorders
Item
known or suspected brain metastasis. serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
boolean
C0220650 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
concurrent tumor therapy
Item
concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (herceptin))
boolean
C0009429 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
peripheral neuropathy, neurological or mental disorder
Item
peripheral neuropathy of common toxicity criteria (ctc) grade greater than 1. history of significant neurological or mental disorder, including seizures or dementia
boolean
C0031117 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0004936 (UMLS CUI [3])

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