ID

38233

Description

Tesetaxel as First-line Therapy for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01221870

Link

https://clinicaltrials.gov/show/NCT01221870

Keywords

Versions (1)
  1. 9/30/19 9/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasm NCT01221870

English

Eligibility Breast Neoplasm NCT01221870

1 forms  
Criteria
Description

Criteria

female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed adenocarcinoma of the breast
Description

Breast adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
stage iv disease
Description

Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
her2 status negative
Description

HER2 Negative

Data type

boolean

Alias
UMLS CUI [1]
C2348908
measurable disease (revised recist; version 1.1)
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
Description

Chemotherapy Absent | Prior Chemotherapy Adjuvant | taxane | Interval Disease Free Duration | Status post Adjuvant therapy Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1522673
UMLS CUI [3]
C0215136
UMLS CUI [4,1]
C1272706
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
UMLS CUI [4,4]
C0449238
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0677850
UMLS CUI [5,3]
C0205197
prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
Description

Prior Hormone Therapy | Aromatase Inhibitors | Prior Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514460
UMLS CUI [2]
C0593802
UMLS CUI [3]
C1514461
prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
Description

Prior radiation therapy Adjuvant Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C0005953
UMLS CUI [1,4]
C0439165
adequate bone marrow, hepatic, and renal function, as specified in the protocol
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
at least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
Description

Effects of Prior Therapy Patient recovered | Operative Surgical Procedures | Prior Hormone Therapy | Aromatase Inhibitors | Prior Immunotherapy | Prior radiation therapy | Pharmacotherapy | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C1115804
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1514460
UMLS CUI [4]
C0593802
UMLS CUI [5]
C1514461
UMLS CUI [6]
C0279134
UMLS CUI [7]
C0013216
UMLS CUI [8]
C0013230
ability to swallow an oral solid-dosage form of medication
Description

Able to swallow Oral medication Solid Dose Form

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [1,3]
C1378566
primary exclusion criteria:
Description

Exclusion Criteria Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205225
known metastasis to the central nervous system
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
history of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
Description

Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
significant medical disease other than stage iv breast cancer
Description

Disease Significant | Exception Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0346993
presence of neuropathy > grade 1 (nci ctc, version 4.0)
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
history of hypersensitivity to a taxane
Description

Hypersensitivity Taxane

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0215136
need to continue any regularly-taken medication that is a potent inhibitor or inducer of the cyp3a pathway or p-glycoprotein activity
Description

CYP3A Inhibitors | CYP3A Inducers | P-Glycoprotein Inhibitors | P-Glycoprotein Activity

Data type

boolean

Alias
UMLS CUI [1]
C3850056
UMLS CUI [2]
C3850044
UMLS CUI [3]
C3500483
UMLS CUI [4]
C1753353
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Similar models

Eligibility Breast Neoplasm NCT01221870

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma
Item
histologically or cytologically confirmed adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
Disease TNM Breast tumor staging
Item
stage iv disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
HER2 Negative
Item
her2 status negative
boolean
C2348908 (UMLS CUI [1])
Measurable Disease
Item
measurable disease (revised recist; version 1.1)
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Chemotherapy Absent | Prior Chemotherapy Adjuvant | taxane | Interval Disease Free Duration | Status post Adjuvant therapy Completion
Item
chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3])
C1272706 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
C0231290 (UMLS CUI [5,1])
C0677850 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
Prior Hormone Therapy | Aromatase Inhibitors | Prior Immunotherapy
Item
prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
boolean
C1514460 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
C1514461 (UMLS CUI [3])
Prior radiation therapy Adjuvant Bone Marrow Percentage
Item
prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
boolean
C0279134 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, hepatic, and renal function, as specified in the protocol
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Effects of Prior Therapy Patient recovered | Operative Surgical Procedures | Prior Hormone Therapy | Aromatase Inhibitors | Prior Immunotherapy | Prior radiation therapy | Pharmacotherapy | Investigational New Drugs
Item
at least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
boolean
C1704420 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C1514460 (UMLS CUI [3])
C0593802 (UMLS CUI [4])
C1514461 (UMLS CUI [5])
C0279134 (UMLS CUI [6])
C0013216 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Able to swallow Oral medication Solid Dose Form
Item
ability to swallow an oral solid-dosage form of medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C1378566 (UMLS CUI [1,3])
Exclusion Criteria Primary
Item
primary exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
CNS metastases
Item
known metastasis to the central nervous system
boolean
C0686377 (UMLS CUI [1])
Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
history of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Disease Significant | Exception Secondary malignant neoplasm of female breast
Item
significant medical disease other than stage iv breast cancer
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Neuropathy CTCAE Grades
Item
presence of neuropathy > grade 1 (nci ctc, version 4.0)
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity Taxane
Item
history of hypersensitivity to a taxane
boolean
C0020517 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
CYP3A Inhibitors | CYP3A Inducers | P-Glycoprotein Inhibitors | P-Glycoprotein Activity
Item
need to continue any regularly-taken medication that is a potent inhibitor or inducer of the cyp3a pathway or p-glycoprotein activity
boolean
C3850056 (UMLS CUI [1])
C3850044 (UMLS CUI [2])
C3500483 (UMLS CUI [3])
C1753353 (UMLS CUI [4])
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