Gender | Age
Item
patient is a female ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
patient has an ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Early-Stage Breast Carcinoma Unilateral | Tumor size Clinical examination | Tumor size Ultrasonography | Tumor size MRI | Disease Multifocal allowed | Disease Multicentric allowed
Item
patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by mri
boolean
C2986665 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
C0475440 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0205292 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0439743 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Tumor tissue sample ER Status | Tumor tissue sample HER2 Status | Tumor tissue sample PI3K Status | Disease HER2 Positive | PIK3CA Gene Mutation Status Known
Item
patient has tumor tissue available for central review of er, her2 and pi3k status with centrally confirmed her2-positive disease and known pi3kca mutation status
boolean
C0475358 (UMLS CUI [1,1])
C1516974 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C1512413 (UMLS CUI [2,2])
C0475358 (UMLS CUI [3,1])
C2936824 (UMLS CUI [3,2])
C0449438 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C2348909 (UMLS CUI [4,2])
C3272694 (UMLS CUI [5,1])
C0449438 (UMLS CUI [5,2])
C0205309 (UMLS CUI [5,3])
Bone Marrow function | Renal function | Liver function
Item
patient has adequate bone marrow, renal and liver function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Able to swallow Oral medication
Item
patient is able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Systemic therapy Previous
Item
patient has received prior systemic treatment for currently diagnosed disease
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Medical contraindication Trastuzumab | Hypersensitivity Trastuzumab | Intolerance to Trastuzumab | Medical contraindication Paclitaxel | Hypersensitivity Paclitaxel | Intolerance to Paclitaxel | Medical contraindication Cremophor Product | Hypersensitivity Cremophor Product | Intolerance to Cremophor Product
Item
patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor
boolean
C1301624 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0144576 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0144576 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0144576 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0056475 (UMLS CUI [7,2])
C1254351 (UMLS CUI [7,3])
C0020517 (UMLS CUI [8,1])
C0056475 (UMLS CUI [8,2])
C1254351 (UMLS CUI [8,3])
C1744706 (UMLS CUI [9,1])
C0056475 (UMLS CUI [9,2])
C1254351 (UMLS CUI [9,3])
Bilateral breast cancer | Neoplasm Metastasis | Inflammatory Breast Carcinoma
Item
patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer
boolean
C0281267 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
lvef below 50% as determined by muga scan or echo
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Heart Disease | Cardiac abnormalities
Item
patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol
boolean
C0018799 (UMLS CUI [1])
C0018798 (UMLS CUI [2])
Gastrointestinal function Impaired | Gastrointestinal Disease Changing Absorption BKM120
Item
patient has impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bkm120
boolean
C0516983 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C3491291 (UMLS CUI [2,4])
Warfarin | Coumarin Derivative Anticoagulants
Item
patient is currently receiving warfarin or other coumarin derived anti-coagulants
boolean
C0043031 (UMLS CUI [1])
C0010206 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
C0003280 (UMLS CUI [2,3])
Adrenal Cortex Hormones chronic | Immunosuppressive Agents chronic
Item
patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
CYP3A Inhibitors Strong | CYP3A Inducers Strong
Item
patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of cyp3a
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850044 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
Score Anxiety Depressed mood Questionnaires
Item
patient has certain scores on an anxiety and depression mood questionnaires
boolean
C0449820 (UMLS CUI [1,1])
C0003467 (UMLS CUI [1,2])
C0344315 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling | Patients Contraceptive methods Unwilling
Item
pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Eligibility Criteria Study Protocol
Item
other protocol defined criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])