ID

36380

Description

A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02); ODM derived from: https://clinicaltrials.gov/show/NCT01989676

Link

https://clinicaltrials.gov/show/NCT01989676

Keywords

Versions (1)
  1. 5/8/19 5/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT01989676

English

Eligibility Metastatic Breast Cancer NCT01989676

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of breast cancer.
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
presence of metastatic disease.
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
documentation of her2 gene amplification or overexpression.
Description

HER2 gene amplification | HER2 Protein Overexpression

Data type

boolean

Alias
UMLS CUI [1]
C1512127
UMLS CUI [2]
C1515560
available tumor tissue for central review of her2 status.
Description

Tumor tissue sample Available | Review of HER2 Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C0699752
UMLS CUI [2,2]
C1512413
at least 1 measurable lesion as defined by recist 1.1.
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
eastern cooperative oncology group status of 0 to 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.
Description

Left ventricular ejection fraction Within reference range Echocardiography 2-Dimensional | Left ventricular ejection fraction Within reference range MUGA scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0460094
UMLS CUI [1,3]
C0013516
UMLS CUI [1,4]
C1705052
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0460094
UMLS CUI [2,3]
C0521317
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy).
Description

Recurrent disease | Adjuvant therapy | Neoadjuvant Therapy | Exception Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0600558
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279025
prior systemic therapy for metastatic disease (except endocrine therapy).
Description

Systemic therapy Neoplasm Metastasis | Exception Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279025
prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of mitoxantrone). if the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin.
Description

Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracyclines Dose Equivalent | Derivative Dose Equivalent | Mitoxantrone Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
UMLS CUI [2,1]
C0014582
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0282564
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205163
UMLS CUI [4,1]
C1527240
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205163
UMLS CUI [5,1]
C0026259
UMLS CUI [5,2]
C0178602
inflammatory breast cancer.
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
active uncontrolled or symptomatic central nervous system metastases.
Description

CNS metastases Uncontrolled | CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
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Similar models

Eligibility Metastatic Breast Cancer NCT01989676

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
histologically confirmed diagnosis of breast cancer.
boolean
C0678222 (UMLS CUI [1])
Neoplasm Metastasis
Item
presence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
HER2 gene amplification | HER2 Protein Overexpression
Item
documentation of her2 gene amplification or overexpression.
boolean
C1512127 (UMLS CUI [1])
C1515560 (UMLS CUI [2])
Tumor tissue sample Available | Review of HER2 Status
Item
available tumor tissue for central review of her2 status.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0699752 (UMLS CUI [2,1])
C1512413 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
at least 1 measurable lesion as defined by recist 1.1.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group status of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Within reference range Echocardiography 2-Dimensional | Left ventricular ejection fraction Within reference range MUGA scan
Item
left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.
boolean
C0428772 (UMLS CUI [1,1])
C0460094 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
C1705052 (UMLS CUI [1,4])
C0428772 (UMLS CUI [2,1])
C0460094 (UMLS CUI [2,2])
C0521317 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Recurrent disease | Adjuvant therapy | Neoadjuvant Therapy | Exception Hormone Therapy
Item
relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy).
boolean
C0277556 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
Systemic therapy Neoplasm Metastasis | Exception Hormone Therapy
Item
prior systemic therapy for metastatic disease (except endocrine therapy).
boolean
C1515119 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracyclines Dose Equivalent | Derivative Dose Equivalent | Mitoxantrone Dose
Item
prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of mitoxantrone). if the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin.
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0014582 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0282564 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205163 (UMLS CUI [3,3])
C1527240 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
C0026259 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
CNS metastases Uncontrolled | CNS metastases Symptomatic
Item
active uncontrolled or symptomatic central nervous system metastases.
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
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