ID

38319

Description

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT01441596

Link

https://clinicaltrials.gov/show/NCT01441596

Keywords

Versions (1)
  1. 10/10/19 10/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01441596

English

Eligibility Breast Neoplasms NCT01441596

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with her2 positive breast cancer with a documented central nervous system (cns) recurrence/progression (by imaging) during or after a her2 inhibitor (trastuzumab and/or lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of cns metastases)
Description

HER2-positive carcinoma of breast | Central Nervous System Recurrence Imaging | Central Nervous System Progression Imaging | HER2 Inhibitor | trastuzumab | lapatinib | Meningeal Carcinomatosis Absent

Data type

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2,1]
C3714787
UMLS CUI [2,2]
C0034897
UMLS CUI [2,3]
C0011923
UMLS CUI [3,1]
C3714787
UMLS CUI [3,2]
C0242656
UMLS CUI [3,3]
C0011923
UMLS CUI [4,1]
C0069515
UMLS CUI [4,2]
C1999216
UMLS CUI [5]
C0728747
UMLS CUI [6]
C1506770
UMLS CUI [7,1]
C0220654
UMLS CUI [7,2]
C0332197
2. at least one measurable and progressive lesion in the brain (=10 mm on t1-weighted, gadolinium-enhanced magnetic resonance imaging). measurable or non measurable extracranial metastases allowed.
Description

Measurable lesion Progressive Quantity Brain | T1 Nuclear magnetic resonance imaging gadolinium-enhanced | Neoplasm Metastasis Extracranial Measurable | Neoplasm Metastasis Extracranial Non-Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0006104
UMLS CUI [2,1]
C2697938
UMLS CUI [2,2]
C0855566
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0580586
UMLS CUI [3,3]
C1513040
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0580586
UMLS CUI [4,3]
C1518373
3. previous treatment with her2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib).
Description

Prior Therapy | HER2 Inhibitor To be stopped | Trastuzumab To be stopped | Lapatinib To be stopped | Antibodies To be stopped

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1999216
UMLS CUI [2,3]
C1272691
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C1272691
UMLS CUI [4,1]
C1506770
UMLS CUI [4,2]
C1272691
UMLS CUI [5,1]
C0003241
UMLS CUI [5,2]
C1272691
4. previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration.
Description

Prior Chemotherapy Adjuvant | Prior Hormone Therapy Adjuvant | Prior Chemotherapy Neoplasm Metastasis | Prior Hormone Therapy Neoplasm Metastasis | Chemotherapy To be stopped | Hormone Therapy To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C1522673
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0027627
UMLS CUI [4,1]
C1514460
UMLS CUI [4,2]
C0027627
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C1272691
UMLS CUI [6,1]
C0279025
UMLS CUI [6,2]
C1272691
5. patients must have recovered to baseline condition or to common terminology criteria for adverse events (ctcae) version 3.0 grade = 1 from any acute ctcae v. 3.0 grade =2 side effects of previous treatments.
Description

Patient recovered | Patient recovered CTCAE Grades | Prior Therapy Side effects CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C1115804
UMLS CUI [2,1]
C1115804
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0879626
UMLS CUI [3,3]
C1516728
6. prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery.
Description

Prior surgery | Whole brain radiation therapy | Radiosurgery, Stereotactic | Metastatic malignant neoplasm to brain New Quantity | Metastatic malignant neoplasm to brain Progressive Quantity | Status post Whole brain radiation therapy Completion | Status post Stereotactic Radiosurgery Completion

Data type

boolean

Alias
UMLS CUI [1]
C0744961
UMLS CUI [2]
C1520143
UMLS CUI [3]
C3846112
UMLS CUI [4,1]
C0220650
UMLS CUI [4,2]
C0205314
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0220650
UMLS CUI [5,2]
C0205329
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1520143
UMLS CUI [6,3]
C0205197
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C3846112
UMLS CUI [7,3]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with her2- tyrosine kinase inhibitor other than lapatinib
Description

Prior Therapy | HER2 Tyrosine kinase inhibitor | Exception Lapatinib

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1268567
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1506770
2. any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).
Description

Cancer Other | Malignant Neoplasms Previous | Exception Bilateral breast cancer | Exception Neoplasm Metastasis Breast Contralateral | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0281267
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C0006141
UMLS CUI [4,4]
C0441988
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699893
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
3. significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. crohn's disease, malabsorption or common terminology criteria (ctc) grade =2 diarrhoea of any aetiology.
Description

Gastrointestinal Diseases chronic | Gastrointestinal Diseases Recent | Diarrhea Symptom Major | Crohn Disease | Malabsorption | Diarrhea CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0011991
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C0205164
UMLS CUI [4]
C0010346
UMLS CUI [5]
C3714745
UMLS CUI [6,1]
C0011991
UMLS CUI [6,2]
C1516728
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Similar models

Eligibility Breast Neoplasms NCT01441596

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
HER2-positive carcinoma of breast | Central Nervous System Recurrence Imaging | Central Nervous System Progression Imaging | HER2 Inhibitor | trastuzumab | lapatinib | Meningeal Carcinomatosis Absent
Item
1. patients with her2 positive breast cancer with a documented central nervous system (cns) recurrence/progression (by imaging) during or after a her2 inhibitor (trastuzumab and/or lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of cns metastases)
boolean
C1960398 (UMLS CUI [1])
C3714787 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C3714787 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
C0011923 (UMLS CUI [3,3])
C0069515 (UMLS CUI [4,1])
C1999216 (UMLS CUI [4,2])
C0728747 (UMLS CUI [5])
C1506770 (UMLS CUI [6])
C0220654 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Measurable lesion Progressive Quantity Brain | T1 Nuclear magnetic resonance imaging gadolinium-enhanced | Neoplasm Metastasis Extracranial Measurable | Neoplasm Metastasis Extracranial Non-Measurable
Item
2. at least one measurable and progressive lesion in the brain (=10 mm on t1-weighted, gadolinium-enhanced magnetic resonance imaging). measurable or non measurable extracranial metastases allowed.
boolean
C1513041 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0006104 (UMLS CUI [1,4])
C2697938 (UMLS CUI [2,1])
C0855566 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0580586 (UMLS CUI [3,2])
C1513040 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0580586 (UMLS CUI [4,2])
C1518373 (UMLS CUI [4,3])
Prior Therapy | HER2 Inhibitor To be stopped | Trastuzumab To be stopped | Lapatinib To be stopped | Antibodies To be stopped
Item
3. previous treatment with her2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib).
boolean
C1514463 (UMLS CUI [1])
C0069515 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C1272691 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C1506770 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C0003241 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Prior Chemotherapy Adjuvant | Prior Hormone Therapy Adjuvant | Prior Chemotherapy Neoplasm Metastasis | Prior Hormone Therapy Neoplasm Metastasis | Chemotherapy To be stopped | Hormone Therapy To be stopped
Item
4. previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration.
boolean
C1514457 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C1514460 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
C0279025 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
Patient recovered | Patient recovered CTCAE Grades | Prior Therapy Side effects CTCAE Grades
Item
5. patients must have recovered to baseline condition or to common terminology criteria for adverse events (ctcae) version 3.0 grade = 1 from any acute ctcae v. 3.0 grade =2 side effects of previous treatments.
boolean
C1115804 (UMLS CUI [1])
C1115804 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Prior surgery | Whole brain radiation therapy | Radiosurgery, Stereotactic | Metastatic malignant neoplasm to brain New Quantity | Metastatic malignant neoplasm to brain Progressive Quantity | Status post Whole brain radiation therapy Completion | Status post Stereotactic Radiosurgery Completion
Item
6. prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery.
boolean
C0744961 (UMLS CUI [1])
C1520143 (UMLS CUI [2])
C3846112 (UMLS CUI [3])
C0220650 (UMLS CUI [4,1])
C0205314 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0220650 (UMLS CUI [5,1])
C0205329 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0231290 (UMLS CUI [6,1])
C1520143 (UMLS CUI [6,2])
C0205197 (UMLS CUI [6,3])
C0231290 (UMLS CUI [7,1])
C3846112 (UMLS CUI [7,2])
C0205197 (UMLS CUI [7,3])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | HER2 Tyrosine kinase inhibitor | Exception Lapatinib
Item
1. prior treatment with her2- tyrosine kinase inhibitor other than lapatinib
boolean
C1514463 (UMLS CUI [1])
C0069515 (UMLS CUI [2,1])
C1268567 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1506770 (UMLS CUI [3,2])
Cancer Other | Malignant Neoplasms Previous | Exception Bilateral breast cancer | Exception Neoplasm Metastasis Breast Contralateral | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
2. any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).
boolean
C1707251 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0281267 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C0006141 (UMLS CUI [4,3])
C0441988 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
Gastrointestinal Diseases chronic | Gastrointestinal Diseases Recent | Diarrhea Symptom Major | Crohn Disease | Malabsorption | Diarrhea CTCAE Grades
Item
3. significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. crohn's disease, malabsorption or common terminology criteria (ctc) grade =2 diarrhoea of any aetiology.
boolean
C0017178 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0011991 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0010346 (UMLS CUI [4])
C3714745 (UMLS CUI [5])
C0011991 (UMLS CUI [6,1])
C1516728 (UMLS CUI [6,2])
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