ID

14817

Description

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

Link

https://clinicaltrials.gov/show/NCT00915369

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 Breast Cancer NCT00915369

Eligibility Advanced Breast Cancer NCT00915369

Inclusion Criteria
Description

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.
Description

advanced breast cancer

Data type

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)
Description

receptor status unknown

Data type

boolean

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

age

Data type

boolean

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

ecog

Data type

boolean

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

measurable lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Description

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+
Description

er/pr positive status

Data type

boolean

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

her2+ detected with fish/cis

Data type

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.
Description

hypersensitivity to paclitaxel or any other taxane

Data type

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).
Description

chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy

Data type

boolean

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

cns lesions

Data type

boolean

Alias
UMLS CUI [1]
C0742468

Similar models

Eligibility Advanced Breast Cancer NCT00915369

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