Gender | Age
Item
1. all patients must be female and at least 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
2. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Locally advanced breast cancer | Locally Advanced Malignant Neoplasm Size | Axillary lymph nodes Involvement | Tumor size Radiology
Item
3. locally advanced breast cancers are eligible. locally advanced cancers must be of clinical and/or radiologic size >3 cm, or >2 cm with clinical evidence of axillary nodal involvement*. (if tumors are less than 3 cm, we will use the radiologically measured tumor size to determine if the tumor meets the minimal size requirements.)
boolean
C3495949 (UMLS CUI [1])
C0677984 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0729594 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
Invasive carcinoma of breast HER2 Protein Overexpression | Immunohistochemistry | Other Coding
Item
4. patients must have histologically confirmed invasive mammary carcinoma that is her2 overexpressing, defined as 3+ by immunohistochemistry, or a fish/cep ratio greater than 2.
boolean
C0853879 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0021044 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
5. negative serum pregnancy test (hcg) within 7 days of starting study drug, if of child-bearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Kidney Function Tests Quantity Times Upper Limit of Normal | Liver Function Tests Quantity Times Upper Limit of Normal
Item
6. kidney and liver function tests - all within 1.5 times the institutional upper limit of normal.
boolean
C0022662 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1632851 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
C0023901 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1632851 (UMLS CUI [2,3])
C1519815 (UMLS CUI [2,4])
WHO performance status scale | ECOG performance status | Life Expectancy
Item
7. performance status (who/ecog scale) 0-1 and life expectancy >6 months.
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Brain Disease Absent | Leptomeningeal disease Absent | Disease TNM clinical staging Absent
Item
8. no evidence of brain or leptomeningeal disease, or any other stage iv disease.
boolean
C0006111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Cancer Other Absent | Exception Carcinoma in situ of uterine cervix Treated Conization | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
9. no previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0195324 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Bilateral breast cancer
Item
1. patients with bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
2. pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Chronic disease Severe
Item
3. severe underlying chronic illness or disease.
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiomyopathy | Left ventricular ejection fraction
Item
4. cardiomyopathy or baseline lvef less than 50%.
boolean
C0878544 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Investigational New Drugs
Item
5. other investigational drugs while on study.
boolean
C0013230 (UMLS CUI [1])
Hypertension, severe | Uncontrolled hypertension | Congestive heart failure | Coronary Artery Disease Severe
Item
6. severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
boolean
C4013784 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C1956346 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Gastrectomy | Small intestine excision | Ulcerative Colitis
Item
7. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. subjects with ulcerative colitis are also excluded
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C0017118 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
Lapatinib Illicit Drugs
Item
8. taking any lapatinib prohibited medication(s)
boolean
C1506770 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
9. inability or unwillingness to comply with, or follow study procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Prior Therapy Breast Carcinoma | Excision | Chemotherapy | Hormone Therapy | Biological treatment
Item
10. patients who have received any form of treatment for breast cancer within the past five years, including surgical resection, chemotherapy, endocrine therapy, or biologic therapy.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
Invasive carcinoma of breast Ipsilateral Previous | Carcinoma in Situ Ipsilateral Previous | Primary tumor New
Item
11. patients with a prior history of ipsilateral invasive breast cancer or carcinoma in situ who present with a new primary.
boolean
C0853879 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0007099 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
Hepatitis B | Hepatitis C | HIV Infection
Item
12. patients with known active, infectious hepatitis b, hepatitis c, or hiv.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])