Adult | Age
Item
adult male or female patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast adenocarcinoma | Neoplasm Metastasis | Recurrent disease Locally | Disease Inappropriate Excision Curative
Item
histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
boolean
C0858252 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0277556 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0728940 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
HER2-positive carcinoma of breast
Item
her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) of at least 50%
boolean
C0428772 (UMLS CUI [1])
Cancer treatment Systemic Neoplasm Metastasis | Cancer treatment Systemic Recurrent disease Locally | Exception Hormone Therapy
Item
previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0277556 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
Interval Disease Free | Completion Adjuvant therapy Systemic | Completion Neoadjuvant Therapy Systemic | Exception Hormone Therapy | Recurrence
Item
disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence </= 6 months
boolean
C1272706 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0205197 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C0205197 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0034897 (UMLS CUI [5])
HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational | Therapeutic procedure Breast Carcinoma | Exception Trastuzumab Adjuvant therapy | Exception Lapatinib Adjuvant therapy | Exception Trastuzumab Neoadjuvant Therapy | Exception Lapatinib Neoadjuvant Therapy
Item
previous approved or investigative anti-her2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
boolean
C2267079 (UMLS CUI [1])
C2267079 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C0677850 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1506770 (UMLS CUI [5,2])
C0677850 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
C0600558 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1506770 (UMLS CUI [7,2])
C0600558 (UMLS CUI [7,3])
Disease Progression | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy
Item
disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
boolean
C0242656 (UMLS CUI [1])
C0728747 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1506770 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C1506770 (UMLS CUI [5,1])
C0600558 (UMLS CUI [5,2])
Toxicity Hematological Persistent CTCAE Grades | Etiology Adjuvant therapy | Etiology Neoadjuvant Therapy
Item
history of persistent grade 2 or higher (nci-ctc, version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
boolean
C0600688 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
CNS metastases
Item
central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
current peripheral neuropathy of grade 3 or greater (nci-ctc, version 4.0)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
history of other malignancy within the last 5 years prior to 1st study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, liver or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Hepatitis B | Hepatitis C | HIV Infection
Item
hepatitis b, hepatitis c or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])