Locally advanced breast cancer HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive
Item
histologically documented human epidermal growth factor receptor 2 (her2)-positive locally advanced or metastatic breast cancer.
boolean
C3495949 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Tumor tissue sample Blocks | Unstained Specimen Quantity | HER2 Status Testing
Item
tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory her2 status testing and other exploratory assessments.
boolean
C0475358 (UMLS CUI [1,1])
C1533157 (UMLS CUI [1,2])
C1883469 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1512413 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
Trastuzumab
Item
prior trastuzumab in any line of therapy.
boolean
C0728747 (UMLS CUI [1])
Trastuzumab emtansine Absent | Pertuzumab Absent
Item
no prior trastuzumab emtansine (t-dm1) or pertuzumab therapy.
boolean
C2935436 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1328025 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease.
boolean
C1513041 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
for women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy ≥ 90 days.
boolean
C0023671 (UMLS CUI [1])
Cancer treatment Recent Breast Carcinoma | Chemotherapy | Biological treatment | Therapy, Investigational | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Exception Hormone replacement therapy | Exception Oral Contraceptives | Exception Palliative Radiation Therapy Bone Marrow Percentage
Item
less than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal, or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives; palliative radiation therapy involving ≤ 25% of marrow-bearing bone if administered ≥ 14 days prior to first study treatment.
boolean
C0920425 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C1522449 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0282402 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0009905 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C3898008 (UMLS CUI [10,2])
C0005953 (UMLS CUI [10,3])
C0439165 (UMLS CUI [10,4])
Intolerance to Trastuzumab | Hypersensitivity Trastuzumab | Adverse event Relationship Trastuzumab
Item
history of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued.
boolean
C1744706 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0728747 (UMLS CUI [3,3])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy of grade ≥ 2.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cardiac dysfunction
Item
history of clinically significant cardiac dysfunction.
boolean
C3277906 (UMLS CUI [1])
Systemic disease Severe Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease
Item
current severe, uncontrolled systemic disease, eg, clinically significant cardiovascular, pulmonary, or metabolic disease.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for
Item
brain metastases that are untreated, progressive, or have required any type of therapy to control symptoms from brain metastases within 60 days of the first study treatment.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated | Exception Treatment outcome Similar Malignant Neoplasms
Item
history of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0085415 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C0006826 (UMLS CUI [4,4])