ID

30613

Descrizione

Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00958971

collegamento

https://clinicaltrials.gov/show/NCT00958971

Keywords

versioni (1)
  1. 18/06/18 18/06/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

18 giugno 2018

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00958971

Inglese

Eligibility Metastatic Breast Cancer NCT00958971

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female presenting with metastatic breast cancer.
Descrizione

Secondary malignant neoplasm of female breast

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0346993
2. tumor must have been tested by fish/cish for fgfr1 amplification.
Descrizione

Tumor FGFR1 Amplification FISH | Tumor FGFR1 Amplification CISH

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1517090
UMLS CUI [1,3]
C0162789
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1517090
UMLS CUI [2,3]
C1516514
3. her2 and hr status must have been determined.
Descrizione

HER2 Status Determination | Hormone Receptor Status Determination

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0521095
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0521095
4. patients must have her2 negative breast cancer.
Descrizione

HER2 negative carcinoma of breast

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2316304
5. patients must have a documented disease progression as define by recist at baseline.
Descrizione

Disease Progression

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0242656
6. patients with hr+ disease:
Descrizione

Hormone receptor positive tumor

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1563119
must have received at least one prior endocrine therapy in the metastatic setting.
Descrizione

Endocrine Therapy Quantity Neoplasm Metastasis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
must have received no more than three lines of chemotherapy in the metastatic setting.
Descrizione

Chemotherapy Line Quantity Neoplasm Metastasis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C4524693
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0027627
7. patients with hr- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
Descrizione

Hormone receptor negative tumor | Chemotherapy Line Quantity Neoplasm Metastasis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4272834
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C4524693
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0027627
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
Descrizione

Metastatic malignant neoplasm to brain | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Lacking

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0220650
UMLS CUI [3,1]
C3897780
UMLS CUI [3,2]
C0332268
2. impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Descrizione

Decreased cardiac function | Heart Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0018799
history or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
Descrizione

Ventricular arrhythmia Serious Uncontrolled | Atrial Fibrillation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0004238
clinically significant resting bradycardia (< 50 beats per minute).
Descrizione

Bradycardia resting Clinical Significance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3278174
UMLS CUI [1,2]
C2826293
lvef assessed by 2-d echocardiogram (echo) or multiple gated acquisition scanning (muga)< 45%.
Descrizione

Left ventricular ejection fraction Echocardiography 2-D | Left ventricular ejection fraction MUGA scan

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [1,3]
C1705052
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
3. any of the following within 6 months prior to study entry: myocardial infarction (mi), severe/unstable angina, coronary artery bypass graft (cabg), congestive heart failure (chf), cerebrovascular accident (cva), transient ischemic attack (tia), pulmonary embolism (pe).
Descrizione

Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0007787
UMLS CUI [8]
C0034065
4. uncontrolled hypertension defined by a sbp > 150mm hg and/or dbp > 100mm hg, with or without anti-hypertensive medication.
Descrizione

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0003364
UMLS CUI [5,1]
C0003364
UMLS CUI [5,2]
C0332197
other protocol-defined inclusion/exclusion criteria may apply
Descrizione

Eligibility Criteria Study Protocol

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Metastatic Breast Cancer NCT00958971

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
1. female presenting with metastatic breast cancer.
boolean
C0346993 (UMLS CUI [1])
Tumor FGFR1 Amplification FISH | Tumor FGFR1 Amplification CISH
Item
2. tumor must have been tested by fish/cish for fgfr1 amplification.
boolean
C0027651 (UMLS CUI [1,1])
C1517090 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1517090 (UMLS CUI [2,2])
C1516514 (UMLS CUI [2,3])
HER2 Status Determination | Hormone Receptor Status Determination
Item
3. her2 and hr status must have been determined.
boolean
C1512413 (UMLS CUI [1,1])
C0521095 (UMLS CUI [1,2])
C0019929 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0521095 (UMLS CUI [2,3])
HER2 negative carcinoma of breast
Item
4. patients must have her2 negative breast cancer.
boolean
C2316304 (UMLS CUI [1])
Disease Progression
Item
5. patients must have a documented disease progression as define by recist at baseline.
boolean
C0242656 (UMLS CUI [1])
Hormone receptor positive tumor
Item
6. patients with hr+ disease:
boolean
C1563119 (UMLS CUI [1])
Endocrine Therapy Quantity Neoplasm Metastasis
Item
must have received at least one prior endocrine therapy in the metastatic setting.
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Chemotherapy Line Quantity Neoplasm Metastasis
Item
must have received no more than three lines of chemotherapy in the metastatic setting.
boolean
C0392920 (UMLS CUI [1,1])
C4524693 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,4])
Hormone receptor negative tumor | Chemotherapy Line Quantity Neoplasm Metastasis
Item
7. patients with hr- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
boolean
C4272834 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C4524693 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0027627 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Lacking
Item
1. patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
boolean
C0220650 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C3897780 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Decreased cardiac function | Heart Diseases
Item
2. impaired cardiac function or clinically significant cardiac diseases, including any of the following:
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Ventricular arrhythmia Serious Uncontrolled | Atrial Fibrillation
Item
history or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
boolean
C0085612 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2])
Bradycardia resting Clinical Significance
Item
clinically significant resting bradycardia (< 50 beats per minute).
boolean
C3278174 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography 2-D | Left ventricular ejection fraction MUGA scan
Item
lvef assessed by 2-d echocardiogram (echo) or multiple gated acquisition scanning (muga)< 45%.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
3. any of the following within 6 months prior to study entry: myocardial infarction (mi), severe/unstable angina, coronary artery bypass graft (cabg), congestive heart failure (chf), cerebrovascular accident (cva), transient ischemic attack (tia), pulmonary embolism (pe).
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C0034065 (UMLS CUI [8])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent
Item
4. uncontrolled hypertension defined by a sbp > 150mm hg and/or dbp > 100mm hg, with or without anti-hypertensive medication.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0003364 (UMLS CUI [4])
C0003364 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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