ID

14598

Description

Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02499146

Link

https://clinicaltrials.gov/show/NCT02499146

Keywords

  1. 23.04.16 23.04.16 -
Uploaded on

23. April 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Advanced Breast Cancer NCT02499146

Eligibility Advanced Breast Cancer NCT02499146

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
er(+), her2(-), postmenopausal adult (ages 18-65 years, inclusive) chinese women with proven diagnosis of adenocarcinoma of the breast with evidence locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
Description

adenocarcinoma of the breast

Data type

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2]
C0152035
postmenopausal women: i. prior bilateral surgical oophorectomy; or ii. medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause b. documentation of histologically or cytologically confirmed diagnosis of: i. er(+) breast cancer. c. documentation of her2(-) breast cancer. d. previously untreated with any systemic anti cancer therapy for their locoregionally recurrent or metastatic er+ disease.
Description

postmenopausal women

Data type

boolean

Alias
UMLS CUI [1]
C0232970
measurable disease as defined per recist v.1.1 or bone-only disease. - tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
Description

Response Evaluation Criteria in Solid Tumors

Data type

boolean

Alias
UMLS CUI [1]
C1709926
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
her2-positive tumor as defined by documentation of erbb-2 gene amplification by fish (as defined by a her2/cep17 ratio ≥2) or chromogenic in situ hybridization (cish, as defined by the manufacturer's kit instruction) or documentation of her2 overexpression by ihc (defined as ihc3+, or ihc2+ with fish or cish confirmation) based on local laboratory results
Description

HER2-positive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C1960398
patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
Description

visceral spread

Data type

boolean

Alias
UMLS CUI [1]
C0027627

Similar models

Eligibility Advanced Breast Cancer NCT02499146

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
adenocarcinoma of the breast
Item
er(+), her2(-), postmenopausal adult (ages 18-65 years, inclusive) chinese women with proven diagnosis of adenocarcinoma of the breast with evidence locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
boolean
C0858252 (UMLS CUI [1])
C0152035 (UMLS CUI [2])
postmenopausal women
Item
postmenopausal women: i. prior bilateral surgical oophorectomy; or ii. medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause b. documentation of histologically or cytologically confirmed diagnosis of: i. er(+) breast cancer. c. documentation of her2(-) breast cancer. d. previously untreated with any systemic anti cancer therapy for their locoregionally recurrent or metastatic er+ disease.
boolean
C0232970 (UMLS CUI [1])
Response Evaluation Criteria in Solid Tumors
Item
measurable disease as defined per recist v.1.1 or bone-only disease. - tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
boolean
C1709926 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HER2-positive carcinoma of breast
Item
her2-positive tumor as defined by documentation of erbb-2 gene amplification by fish (as defined by a her2/cep17 ratio ≥2) or chromogenic in situ hybridization (cish, as defined by the manufacturer's kit instruction) or documentation of her2 overexpression by ihc (defined as ihc3+, or ihc2+ with fish or cish confirmation) based on local laboratory results
boolean
C1960398 (UMLS CUI [1])
visceral spread
Item
patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
boolean
C0027627 (UMLS CUI [1])

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