ID

38195

Description

Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca; ODM derived from: https://clinicaltrials.gov/show/NCT02144194

Link

https://clinicaltrials.gov/show/NCT02144194

Keywords

Versions (1)
  1. 9/26/19 9/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02144194

English

Eligibility Breast Cancer NCT02144194

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients >=18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
Description

Breast adenocarcinoma metastatic Inoperable Curative intent | Breast adenocarcinoma recurrent Locally Inoperable Curative intent

Data type

boolean

Alias
UMLS CUI [1,1]
C1697918
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C1276305
UMLS CUI [2,1]
C0861355
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C0205187
UMLS CUI [2,4]
C1276305
measurable and/or non-measurable disease
Description

Measurable Disease | Non-Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
the patient's primary and/or metastatic tumor is her2 neu negative
Description

Primary tumor HER2/Neu Negative | Metastatic Neoplasm HER2/Neu Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2348908
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C2348908
documented metastatic disease previously untreated with palliative chemotherapy
Description

Neoplasm Metastasis | Chemotherapy Palliative Absent

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1285530
UMLS CUI [2,3]
C0332197
adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
Description

Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | docetaxel | Chemotherapy | Disease-Free Survival Duration

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [3]
C0246415
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C0242793
UMLS CUI [5,2]
C0449238
no symptom or sign of brain metastasis
Description

Sign or Symptom Absent Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0220650
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
operable local recurrence
Description

Recurrence Local Operable

Data type

boolean

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205188
ascites or pericardial effusion as only site of metastasis
Description

Ascites | Pericardial effusion | Site only Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0031039
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0205171
UMLS CUI [3,3]
C0027627
symptomatic peripheral neuropathy > grade 1 according to the nci common toxicity criteria
Description

Peripheral Neuropathy Symptomatic CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1516728
radiotherapy to all areas of evaluable disease within the previous 4 weeks
Description

Therapeutic radiology procedure Area Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1516986
disease significantly affecting absorption
Description

Disease Affecting Absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
severe hepatic insufficiency
Description

Hepatic Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0205082
patient previously treated with chemotherapy for their metastatic disease
Description

Prior Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
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Similar models

Eligibility Breast Cancer NCT02144194

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
patients >=18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma metastatic Inoperable Curative intent | Breast adenocarcinoma recurrent Locally Inoperable Curative intent
Item
histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
boolean
C1697918 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C0861355 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0205187 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
Measurable Disease | Non-Measurable Lesion
Item
measurable and/or non-measurable disease
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
Primary tumor HER2/Neu Negative | Metastatic Neoplasm HER2/Neu Negative
Item
the patient's primary and/or metastatic tumor is her2 neu negative
boolean
C0677930 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C2939420 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Neoplasm Metastasis | Chemotherapy Palliative Absent
Item
documented metastatic disease previously untreated with palliative chemotherapy
boolean
C0027627 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1285530 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | docetaxel | Chemotherapy | Disease-Free Survival Duration
Item
adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
boolean
C0085533 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0246415 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0242793 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
Sign or Symptom Absent Metastatic malignant neoplasm to brain
Item
no symptom or sign of brain metastasis
boolean
C3540840 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0220650 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Recurrence Local Operable
Item
operable local recurrence
boolean
C0034897 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
Ascites | Pericardial effusion | Site only Neoplasm Metastasis
Item
ascites or pericardial effusion as only site of metastasis
boolean
C0003962 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C1515974 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
Peripheral Neuropathy Symptomatic CTCAE Grades
Item
symptomatic peripheral neuropathy > grade 1 according to the nci common toxicity criteria
boolean
C0031117 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Therapeutic radiology procedure Area Evaluable Disease
Item
radiotherapy to all areas of evaluable disease within the previous 4 weeks
boolean
C1522449 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1516986 (UMLS CUI [1,3])
Disease Affecting Absorption
Item
disease significantly affecting absorption
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
Hepatic Insufficiency Severe
Item
severe hepatic insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Prior Chemotherapy Neoplasm Metastasis
Item
patient previously treated with chemotherapy for their metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
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