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])
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])