Invasive carcinoma of breast TNM clinical staging
Item
histologically or cytologically confirmed invasive breast cancer, with stage iv disease
boolean
C0853879 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
HER2-positive carcinoma of breast | Staining method Immunohistochemistry | Gene Amplification Fluorescent in Situ Hybridization
Item
her2-positive breast cancer, defined as 3+ staining by ihc or gene amplification by fish
boolean
C1960398 (UMLS CUI [1])
C0487602 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C0017256 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
Measurable Disease | Lesion Quantity | Measurement Dimension Quantity
Item
measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Recurrent disease Biopsy Willing | Neoplasm Metastasis Biopsy Willing
Item
willingness to undergo a research biopsy of recurrent or metastatic disease
boolean
C0277556 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Chemotherapy To be stopped
Item
prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry.
boolean
C0392920 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Therapeutic radiology procedure Completed
Item
completed radiation therapy at least 7 days prior to beginning protocol treatment
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Advanced breast cancer | Chemotherapy Absent | Trastuzumab Absent | Lapatinib Absent | HER2 Targeted Therapy Absent
Item
cohort 1: no prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other her2-directed therapy other than trastuzumab
boolean
C3495917 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1506770 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0069515 (UMLS CUI [5,1])
C2985566 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Chemotherapy Quantity Advanced breast cancer | Lapatinib Absent | HER2 Targeted Therapy Absent | Trastuzumab Excluded
Item
cohort 2: up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other her2-directed therapy except for trastuzumab
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495917 (UMLS CUI [1,3])
C1506770 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0728747 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
normal organ and marrow function as outlined in protocol
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Cardiac ejection fraction | Multiple gated acquisition scanning | Echocardiography
Item
cardiac ejection fraction, as assessed by either muga scan or echocardiogram greater than or equal to 50%
boolean
C0232174 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
Able to swallow oral medication
Item
able to take oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Investigational New Drugs Neoplasm Metastasis | Chemotherapy Neoplasm Metastasis | Hormone Therapy Neoplasm Metastasis
Item
patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease
boolean
C0013230 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain
Item
active brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Lapatinib Compound Similar | Allergic Reaction Investigational New Drugs
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study
boolean
C1527304 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Malabsorption Syndrome
Item
clinically significant malabsorption syndrome
boolean
C0024523 (UMLS CUI [1])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Study Protocol Interaction Lapatinib
Item
concurrent use of the medications listed in the protocol because of possible interaction with lapatinib
boolean
C0013227 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0687133 (UMLS CUI [1,3])
C1506770 (UMLS CUI [1,4])