ID

30613

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00958971

Nyckelord

Versioner (1)
  1. 2018-06-18 2018-06-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00958971

Engelsk

Eligibility Metastatic Breast Cancer NCT00958971

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Secondary malignant neoplasm of female breast

Datatyp

boolean

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

Tumor FGFR1 Amplification FISH | Tumor FGFR1 Amplification CISH

Datatyp

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.
Beskrivning

HER2 Status Determination | Hormone Receptor Status Determination

Datatyp

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.
Beskrivning

HER2 negative carcinoma of breast

Datatyp

boolean

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

Disease Progression

Datatyp

boolean

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

Hormone receptor positive tumor

Datatyp

boolean

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

Endocrine Therapy Quantity Neoplasm Metastasis

Datatyp

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.
Beskrivning

Chemotherapy Line Quantity Neoplasm Metastasis

Datatyp

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.
Beskrivning

Hormone receptor negative tumor | Chemotherapy Line Quantity Neoplasm Metastasis

Datatyp

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
Beskrivning

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.
Beskrivning

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

Datatyp

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:
Beskrivning

Decreased cardiac function | Heart Diseases

Datatyp

boolean

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

Ventricular arrhythmia Serious Uncontrolled | Atrial Fibrillation

Datatyp

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).
Beskrivning

Bradycardia resting Clinical Significance

Datatyp

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%.
Beskrivning

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

Datatyp

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).
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

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

Eligibility Metastatic Breast Cancer NCT00958971

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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