ID

14817

Beskrivning

A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00915369

Länk

https://clinicaltrials.gov/show/NCT00915369

Nyckelord

  1. 2016-04-29 2016-04-29 -
Uppladdad den

29 april 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Advanced Breast Cancer NCT00915369

Eligibility Advanced Breast Cancer NCT00915369

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
Beskrivning

advanced breast cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3495917
UMLS CUI [1,2]
C0205269
patients with er/pr -ve or er/pr receptor status unknown (defined as no histopathological evidence for confirmation of er/pr status)
Beskrivning

receptor status unknown

Datatyp

boolean

Alias
UMLS CUI [1]
C0279758
patients must be of 18-65 years of age (inclusive of both)
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with ecog performance status between 0 - 2
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patients with at least one measurable lesion as per recist
Beskrivning

measurable lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with er/pr positive status. patients who demonstrate her2 over expression will be excluded. alternatively, the patients enrolled should have previously received trastuzumab. her2 over expression should be demonstrated by ihc 3+, ihc 2+
Beskrivning

er/pr positive status

Datatyp

boolean

Alias
UMLS CUI [1]
C1719706
UMLS CUI [2]
C0069515
her2+ detected with fish/cis
Beskrivning

her2+ detected with fish/cis

Datatyp

boolean

Alias
UMLS CUI [1]
C2316574
patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
Beskrivning

hypersensitivity to paclitaxel or any other taxane

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0215136
patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (patients requiring local radiotherapy for non- target bone lesion will be included).
Beskrivning

chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
patients with known cns lesions (brain metastasis or carcinomatous meningitis).
Beskrivning

cns lesions

Datatyp

boolean

Alias
UMLS CUI [1]
C0742468

Similar models

Eligibility Advanced Breast Cancer NCT00915369

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
advanced breast cancer
Item
female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
boolean
C3495917 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
receptor status unknown
Item
patients with er/pr -ve or er/pr receptor status unknown (defined as no histopathological evidence for confirmation of er/pr status)
boolean
C0279758 (UMLS CUI [1])
age
Item
patients must be of 18-65 years of age (inclusive of both)
boolean
C0001779 (UMLS CUI [1])
ecog
Item
patients with ecog performance status between 0 - 2
boolean
C1520224 (UMLS CUI [1])
measurable lesion
Item
patients with at least one measurable lesion as per recist
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
er/pr positive status
Item
patients with er/pr positive status. patients who demonstrate her2 over expression will be excluded. alternatively, the patients enrolled should have previously received trastuzumab. her2 over expression should be demonstrated by ihc 3+, ihc 2+
boolean
C1719706 (UMLS CUI [1])
C0069515 (UMLS CUI [2])
her2+ detected with fish/cis
Item
her2+ detected with fish/cis
boolean
C2316574 (UMLS CUI [1])
hypersensitivity to paclitaxel or any other taxane
Item
patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy
Item
patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (patients requiring local radiotherapy for non- target bone lesion will be included).
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
cns lesions
Item
patients with known cns lesions (brain metastasis or carcinomatous meningitis).
boolean
C0742468 (UMLS CUI [1])

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