ID

35010

Description

Defining an Exposure Target for Weekly Paclitaxel Infusion in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02338115

Link

https://clinicaltrials.gov/show/NCT02338115

Keywords

Versions (1)
  1. 2/8/19 2/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02338115

English

Eligibility Breast Cancer NCT02338115

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of invasive breast cancer
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
systemic treatment with paclitaxel for curative intent (neoadjuvant, adjuvant, or oligometastatic disease per pi discretion)
Description

Paclitaxel | Systemic therapy Curative | Neoadjuvant Therapy Disease | Adjuvant therapy Disease | Neoplasm Metastasis Few

Data type

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1276305
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0012634
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0012634
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0205388
80 mg/m2 1-hour infusions weekly for up to 12 weeks
Description

Infusions U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0560588
female sex
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
>18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand and the willingness to sign a written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior or concurrent treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum, bortezomib, or thalidomide. note that concurrent biologic treatment with trastuzumab/pertuzumab for her2+ patients or prior treatment with adriamycin/cyclophosphamide are not reasons for exclusion.
Description

Chemotherapy Neurotoxic agents | taxane | Vinca Alkaloids | Platinum | bortezomib | Thalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0260049
UMLS CUI [2]
C0215136
UMLS CUI [3]
C0042672
UMLS CUI [4]
C0032207
UMLS CUI [5]
C1176309
UMLS CUI [6]
C0039736
distant metastatic disease
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
concurrent treatment with duloxetine or enrollment on clinical study of neuroprotective agent
Description

duloxetine | Study Subject Participation Status | Neuroprotective Agents

Data type

boolean

Alias
UMLS CUI [1]
C0245561
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0242912
history of allergic reaction to paclitaxel or cremophor el
Description

Paclitaxel allergy | Hypersensitivity Cremophor EL

Data type

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0056476
current signs or symptoms of severe peripheral neuropathy
Description

Sign or Symptom Peripheral Neuropathy Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0031117
UMLS CUI [1,3]
C0205082
known family history of hereditary peripheral neuropathy or charcot-marie-tooth disease
Description

Family history Hereditary peripheral neuropathy | Family history of Charcot-Marie-Tooth disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0392553
UMLS CUI [2]
C2316866
known current pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Breast Cancer NCT02338115

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
diagnosis of invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Paclitaxel | Systemic therapy Curative | Neoadjuvant Therapy Disease | Adjuvant therapy Disease | Neoplasm Metastasis Few
Item
systemic treatment with paclitaxel for curative intent (neoadjuvant, adjuvant, or oligometastatic disease per pi discretion)
boolean
C0144576 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0027627 (UMLS CUI [5,1])
C0205388 (UMLS CUI [5,2])
Infusions U/week
Item
80 mg/m2 1-hour infusions weekly for up to 12 weeks
boolean
C0574032 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
Gender
Item
female sex
boolean
C0079399 (UMLS CUI [1])
Age
Item
>18 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Neurotoxic agents | taxane | Vinca Alkaloids | Platinum | bortezomib | Thalidomide
Item
any prior or concurrent treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum, bortezomib, or thalidomide. note that concurrent biologic treatment with trastuzumab/pertuzumab for her2+ patients or prior treatment with adriamycin/cyclophosphamide are not reasons for exclusion.
boolean
C0392920 (UMLS CUI [1,1])
C0260049 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2])
C0042672 (UMLS CUI [3])
C0032207 (UMLS CUI [4])
C1176309 (UMLS CUI [5])
C0039736 (UMLS CUI [6])
Distant metastasis
Item
distant metastatic disease
boolean
C1269798 (UMLS CUI [1])
duloxetine | Study Subject Participation Status | Neuroprotective Agents
Item
concurrent treatment with duloxetine or enrollment on clinical study of neuroprotective agent
boolean
C0245561 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0242912 (UMLS CUI [3])
Paclitaxel allergy | Hypersensitivity Cremophor EL
Item
history of allergic reaction to paclitaxel or cremophor el
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0056476 (UMLS CUI [2,2])
Sign or Symptom Peripheral Neuropathy Severe
Item
current signs or symptoms of severe peripheral neuropathy
boolean
C3540840 (UMLS CUI [1,1])
C0031117 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Family history Hereditary peripheral neuropathy | Family history of Charcot-Marie-Tooth disease
Item
known family history of hereditary peripheral neuropathy or charcot-marie-tooth disease
boolean
C0241889 (UMLS CUI [1,1])
C0392553 (UMLS CUI [1,2])
C2316866 (UMLS CUI [2])
Pregnancy
Item
known current pregnancy
boolean
C0032961 (UMLS CUI [1])
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