Age
Item
1. female or male ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
2. who performance status ≤ 1
boolean
C1298650 (UMLS CUI [1])
Locally advanced breast cancer HER2 Positive | Breast cancer recurrent HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive | Immunohistochemistry | FISH Positive | Trastuzumab failed
Item
3. locally advanced, recurrent or metastatic, histologically confirmed her2 positive (ihc 3+ or fish positive) breast cancer after failure of trastuzumab treatment.
boolean
C3495949 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0346993 (UMLS CUI [3,1])
C2348909 (UMLS CUI [3,2])
C0021044 (UMLS CUI [4])
C0162789 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C0728747 (UMLS CUI [6,1])
C0231175 (UMLS CUI [6,2])
Trastuzumab Adjuvant therapy Neoplasm Metastasis | Trastuzumab Neoadjuvant Therapy Neoplasm Metastasis
Item
while on trastuzumab or within 4 weeks since the last infusion of trastuzumab for metastatic disease within 12 months of the last infusion for patients who received trastuzumab as adjuvant or neoadjuvant treatment
boolean
C0728747 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Disease Progression | trastuzumab
Item
4. for the phase ii part, progression on trastuzumab must have occurred within 16 weeks before entering this trial.
boolean
C0242656 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
Targeted Therapy Quantity HER2
Item
5. should not have received more than 3 lines of anti-her2 therapy.
boolean
C2985566 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
Activation PI3K/AKT1 Signaling Pathway
Item
6. for the phase ii part, activation of pi3k/akt pathway
boolean
C1879547 (UMLS CUI [1,1])
C2984369 (UMLS CUI [1,2])
Informed Consent
Item
7. capable of understanding the protocol and has signed the informed consent
boolean
C0021430 (UMLS CUI [1])
Normal Laboratory Test Result
Item
8. laboratory values within normal range
boolean
C0438214 (UMLS CUI [1])
Measurable Disease
Item
9. measurable disease
boolean
C1513041 (UMLS CUI [1])
Therapeutic procedure Metastatic malignant neoplasm to brain | Stable status Neurologic
Item
10. patients may have received treatment for brain metastases, but must be neurologically stable
boolean
C0087111 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0205360 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
11. baseline lvef>50% (muga or echo)
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Affiliation Social Security Program
Item
12. affiliation to social security
boolean
C1510825 (UMLS CUI [1,1])
C0037435 (UMLS CUI [1,2])
Prior Therapy | lapatinib | neratinib | PI3K Inhibitor
Item
1. previous treatment with lapatinib, neratinib or a pi3k inhibitor
boolean
C1514463 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C2713008 (UMLS CUI [3])
C1519050 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Untreated
Item
2. untreated brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Liver disease | Kidney Disease | Pancreatitis | Chronic liver disease | Chronic Kidney Disease | Pancreatitis, Chronic
Item
3. acute or chronic liver, renal disease or pancreatitis
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
C0341439 (UMLS CUI [4])
C1561643 (UMLS CUI [5])
C0149521 (UMLS CUI [6])
Peripheral Neuropathy CTCAE Grades
Item
4. any peripheral neuropathy ≥ ctcae grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Mood Disorders | PHQ-9 | GAD-7 | Feeling suicidal PHQ-9
Item
5. any of the following mood disorders, or meets the cut-off score of ≥ 10 in the phq-9 or a cut-off of ≥ 15 in the gad-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the phq-9 (independent of the total score of the phq-9)
boolean
C0525045 (UMLS CUI [1])
C4083201 (UMLS CUI [2])
C3641330 (UMLS CUI [3])
C0424000 (UMLS CUI [4,1])
C4083201 (UMLS CUI [4,2])
Major depressive episode | Bipolar I disorder | Bipolar II disorder | Obsessive-Compulsive Disorder | Schizophrenia | Suicide attempt | Feeling suicidal | Homicidal thoughts | Risk of violence or harm to others
Item
medically documented history of or active major depressive episode, bipolar disorder (i or ii), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
boolean
C0024517 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
C0236788 (UMLS CUI [3])
C0028768 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0038663 (UMLS CUI [6])
C0424000 (UMLS CUI [7])
C0455204 (UMLS CUI [8])
C0549013 (UMLS CUI [9])
Anxiety CTCAE Grades
Item
≥ ctcae grade 3 anxiety
boolean
C0003467 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Diarrhea CTCAE Grades
Item
6. diarrhea ≥ ctcae grade 2
boolean
C0011991 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Heart Disease
Item
7. active cardiac disease
boolean
C0018799 (UMLS CUI [1])
Cardiac dysfunction
Item
8. history of cardiac dysfunction
boolean
C3277906 (UMLS CUI [1])
Poorly controlled diabetes mellitus | Hemoglobin A1c measurement
Item
9. poorly controlled diabetes mellitus (hba1c > 8 %)
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Comorbidity Severe | Comorbidity Uncontrolled
Item
10. other severe and/or uncontrolled concomitant medical conditions
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Abnormal digestive tract function Changing Absorption BKM120
Item
11. impairment of gastrointestinal function that may significantly alter the absorption of bkm120
boolean
C0232459 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C3491291 (UMLS CUI [1,4])
Colony-Stimulating Factors Hematopoietic
Item
12. been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
boolean
C0009392 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
Pharmacotherapy At risk Prolonged QT interval | Pharmacotherapy Inducing Torsades de Pointes
Item
13. currently receiving treatment with medication with a known risk prolong the qt interval or inducing torsades de pointes
boolean
C0013216 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
CYP3A Inhibitors Moderate | CYP3A Inducers Moderate | CYP3A Inhibitors Strong | CYP3A Inducers Strong
Item
14. currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme cyp3a
boolean
C3850056 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3850044 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3850056 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3850044 (UMLS CUI [4,1])
C0442821 (UMLS CUI [4,2])
Steroids chronic | Immunosuppressive Agents chronic
Item
15. receiving chronic treatment with steroids or another immunosuppressive agent.
boolean
C0038317 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Chemotherapy | Targeted Therapy Malignant Neoplasms | Nitrosoureas | Antibodies | Exception Trastuzumab | Mitomycin | Therapy Side effects Recovery Lacking
Item
16. have received chemotherapy or targeted anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies [other than trastuzumab] or mitomycin-c) prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C0392920 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0028210 (UMLS CUI [3])
C0003241 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0728747 (UMLS CUI [5,2])
C0002475 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0879626 (UMLS CUI [7,2])
C2004454 (UMLS CUI [7,3])
C0332268 (UMLS CUI [7,4])
Small Molecule therapeutics | Exception Monoclonal Antibodies | Therapy Side effects Recovery Lacking
Item
17. have received small molecule therapeutics (excluding monoclonal antibodies) ≤ 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C1328819 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003250 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
Extended-Field Radiation Therapy Disease palliation | Therapy Radiation Field Limited Disease palliation | Therapy Side effects Recovery Lacking
Item
18. have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C3826855 (UMLS CUI [1,1])
C0679251 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1882536 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0679251 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
Major surgery | Major surgery Side effects Recovery Lacking
Item
19. have undergone major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C2004454 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
HIV Infection
Item
20. known diagnosis of hiv infection
boolean
C0019693 (UMLS CUI [1])
Cancer Other
Item
21. history of another malignancy within 3 years
boolean
C1707251 (UMLS CUI [1])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
22. patient is unable or unwilling to abide by the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
23. pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])