ID

23703

Description

An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00580112

Link

https://clinicaltrials.gov/show/NCT00580112

Keywords

Versions (1)
  1. 7/11/17 7/11/17 -
Uploaded on

July 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00580112

English

Eligibility Breast Neoplasms NCT00580112

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with histologically proven diagnosis of progressive metastatic breast cancer
Description

Secondary malignant neoplasm of female breast Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C0205329
participants with measurable disease as per the response evaluation criteria in solid tumors (recist) guidelines
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
participants with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present
Description

Secondary malignant neoplasm of bone | Diphosphonates Palliative Care | Measurable Disease Site

Data type

boolean

Alias
UMLS CUI [1]
C0153690
UMLS CUI [2,1]
C0012544
UMLS CUI [2,2]
C0030231
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1515974
participants with eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 and adequately recovered from the acute toxicity of any prior treatment
Description

ECOG performance status | Toxicity Due to Prior Therapy | Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1514463
UMLS CUI [3]
C1115804
participants with serum creatinine less than or equal to 1.5 milligram per deciliter (mg/dl) or creatinine clearance greater than or equal to 30 milliliter per minute (ml/min)
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with previous exposure to trabectedin
Description

Exposure to trabectedin

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1311070
participants with more than 3 previous chemotherapy regimens for metastatic disease and known hypersensitivity to components of trabectedin intravenous formulation or dexamethasone
Description

Chemotherapy Regimen Quantity Neoplasm Metastasis | Hypersensitivity Component Trabectedin Intravenous | Dexamethasone allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C1311070
UMLS CUI [2,4]
C1522726
UMLS CUI [3]
C0571611
pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
completion of previous therapy : less than 2 weeks from radiation therapy or last dose of hormonal therapy, less than 3 weeks from previous biological therapy or chemotherapy
Description

Prior Therapy Completion | Therapeutic radiology procedure | Hormone Therapy | Biological treatment | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C1531518
UMLS CUI [5]
C0392920
participants with known leptomeningeal disease and other serious illnesses like congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias or active infection or psychiatric disorder or active viral hepatitis
Description

Leptomeningeal disease | Illness Serious | Congestive heart failure | Angina Pectoris | Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia | Communicable Diseases | Mental disorders | Viral hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0751297
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0027051
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0003811
UMLS CUI [8]
C0009450
UMLS CUI [9]
C0004936
UMLS CUI [10]
C0042721
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Similar models

Eligibility Breast Neoplasms NCT00580112

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast Progressive
Item
participants with histologically proven diagnosis of progressive metastatic breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Measurable Disease
Item
participants with measurable disease as per the response evaluation criteria in solid tumors (recist) guidelines
boolean
C1513041 (UMLS CUI [1])
Secondary malignant neoplasm of bone | Diphosphonates Palliative Care | Measurable Disease Site
Item
participants with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present
boolean
C0153690 (UMLS CUI [1])
C0012544 (UMLS CUI [2,1])
C0030231 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
ECOG performance status | Toxicity Due to Prior Therapy | Patient recovered
Item
participants with eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 and adequately recovered from the acute toxicity of any prior treatment
boolean
C1520224 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Creatinine measurement, serum | Creatinine clearance measurement
Item
participants with serum creatinine less than or equal to 1.5 milligram per deciliter (mg/dl) or creatinine clearance greater than or equal to 30 milliliter per minute (ml/min)
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exposure to trabectedin
Item
participants with previous exposure to trabectedin
boolean
C0332157 (UMLS CUI [1,1])
C1311070 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity Neoplasm Metastasis | Hypersensitivity Component Trabectedin Intravenous | Dexamethasone allergy
Item
participants with more than 3 previous chemotherapy regimens for metastatic disease and known hypersensitivity to components of trabectedin intravenous formulation or dexamethasone
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C1311070 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
C0571611 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Prior Therapy Completion | Therapeutic radiology procedure | Hormone Therapy | Biological treatment | Chemotherapy
Item
completion of previous therapy : less than 2 weeks from radiation therapy or last dose of hormonal therapy, less than 3 weeks from previous biological therapy or chemotherapy
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
Leptomeningeal disease | Illness Serious | Congestive heart failure | Angina Pectoris | Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia | Communicable Diseases | Mental disorders | Viral hepatitis
Item
participants with known leptomeningeal disease and other serious illnesses like congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias or active infection or psychiatric disorder or active viral hepatitis
boolean
C0751297 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0042721 (UMLS CUI [10])
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