Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Secondary malignant neoplasm of female breast HER2 Positive
Item
histologically or cytologically confirmed her2-positive metastatic breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
First line treatment Herceptin Intravenous | Free of Disease Progression
Item
on treatment with first-line herceptin iv and free of disease progression for at least 3 years
boolean
C1708063 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
C0332296 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) of >/= 50%
boolean
C0428772 (UMLS CUI [1])
Hormone Therapy
Item
hormonal therapy will be allowed
boolean
C0279025 (UMLS CUI [1])
HER2 Targeted Therapy
Item
prior use of anti-her2 therapy will be allowed
boolean
C0069515 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration | Exception DCIS
Item
history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies who have been disease-free for at least 5 years; patients with previous ductal carcinoma in situ of the breast are also eligible
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0007124 (UMLS CUI [6,2])
Resting Dyspnea Severe | Requirement Oxygen supplementation
Item
patients with severe dyspnea at rest or requiring supplementary oxygen therapy
boolean
C0743330 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0919655 (UMLS CUI [2,2])
Heart Disease Serious | Medical condition Excludes Herceptin
Item
serious cardiac illness or medical conditions that would preclude the use of herceptin
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0338204 (UMLS CUI [2,3])
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])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial | Cancer treatment Investigational | Hormone Therapy | Diphosphonates | Immunotherapy
Item
concurrent enrolment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4])
C0012544 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
Hypersensitivity Trastuzumab | Hypersensitivity Murine protein | Hypersensitivity Herceptin Excipient | Hyaluronidase allergy | Hypersensitivity Adhesive Device subcutaneous | Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control
Item
known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0572015 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0001516 (UMLS CUI [5,2])
C0025080 (UMLS CUI [5,3])
C0443315 (UMLS CUI [5,4])
C2220378 (UMLS CUI [6])
C0301873 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0332218 (UMLS CUI [8,1])
C0004096 (UMLS CUI [8,2])
C2587213 (UMLS CUI [8,3])
CNS metastases | Exception CNS metastases Treated | Exception CNS metastases Stable
Item
central nervous system (cns) metastases unless they have been treated and have been stable for at least 3 months
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0686377 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Organ function Inadequate
Item
inadequate organ function
boolean
C0678852 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])