ID

14821

Description

Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01625286

Link

https://clinicaltrials.gov/show/NCT01625286

Keywords

  1. 4/29/16 4/29/16 -
Uploaded on

April 29, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Advanced or Metastatic Breast Cancer, NCT01625286

Eligibility Advanced or Metastatic Breast Cancer, NCT01625286

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
female patient
Description

female patient

Data type

boolean

Alias
UMLS CUI [1]
C0150905
aged at least 18 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be er+ve, her2-ve, in part b).
Description

breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0678222
world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
Description

who performance status

Data type

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant abnormalities of glucose metabolism
Description

clinically significant abnormalities of glucose metabolism

Data type

boolean

Alias
UMLS CUI [1]
C0744434
spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
Description

spinal cord compression

Data type

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0220650
evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and hiv.
Description

systemic diseases, bleeding diatheses

Data type

boolean

Alias
UMLS CUI [1]
C1536063
UMLS CUI [2]
C0442893
any prior exposure to agents which inhibit akt as the primary pharmacological activity.
Description

inhibit akt

Data type

boolean

Alias
UMLS CUI [1]
C0812228
part a: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
part b: any prior chemotherapy for advanced or metastatic breast cancer.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0278488

Similar models

Eligibility Advanced or Metastatic Breast Cancer, NCT01625286

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
provision of informed consent
boolean
C0021430 (UMLS CUI [1])
female patient
Item
female patient
boolean
C0150905 (UMLS CUI [1])
age
Item
aged at least 18 years
boolean
C0001779 (UMLS CUI [1])
breast cancer
Item
histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be er+ve, her2-ve, in part b).
boolean
C0678222 (UMLS CUI [1])
who performance status
Item
world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
boolean
C1298650 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
clinically significant abnormalities of glucose metabolism
Item
clinically significant abnormalities of glucose metabolism
boolean
C0744434 (UMLS CUI [1])
spinal cord compression
Item
spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
systemic diseases, bleeding diatheses
Item
evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and hiv.
boolean
C1536063 (UMLS CUI [1])
C0442893 (UMLS CUI [2])
inhibit akt
Item
any prior exposure to agents which inhibit akt as the primary pharmacological activity.
boolean
C0812228 (UMLS CUI [1])
chemotherapy
Item
part a: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer.
boolean
C0392920 (UMLS CUI [1])
chemotherapy
Item
part b: any prior chemotherapy for advanced or metastatic breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])

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