Locally advanced breast cancer | Secondary malignant neoplasm of female breast | Measurable Disease | Non-Measurable Lesion | Evaluable Disease
Item
histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C1513041 (UMLS CUI [3])
C1334988 (UMLS CUI [4])
C1516986 (UMLS CUI [5])
Disease HER2 Positive
Item
her2-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Trastuzumab
Item
history of prior trastuzumab therapy
boolean
C0728747 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 90 days as assessed by the investigator
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative
Item
negative urine pregnancy test ≤ 72 hours prior to cycle 1 day 1 for all women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Quantity | T-DM1 | Pertuzumab
Item
for patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of t-dm1 or 6 months after the last dose of pertuzumab, if applicable
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2935436 (UMLS CUI [2])
C1328025 (UMLS CUI [3])
Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma | Immunotherapy Breast Carcinoma | Biological treatment Breast Carcinoma
Item
any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0021083 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C1531518 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
T-DM1 | Pertuzumab
Item
prior t-dm1 or pertuzumab therapy
boolean
C2935436 (UMLS CUI [1])
C1328025 (UMLS CUI [2])
Intolerance to Trastuzumab | Infusion reaction Trastuzumab CTCAE Grades | Adverse event Trastuzumab
Item
history of intolerance (such as grade 3-4 infusion reaction) and/or adverse events related to trastuzumab
boolean
C1744706 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C2368034 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0877248 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
Peripheral Neuropathy CTCAE Grades
Item
grade ≥ 2 (based on national cancer institute common terminology criteria for adverse events [nci ctcae] v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for | Therapeutic radiology procedure | Operative Surgical Procedures | Steroids | Symptom control Metastatic malignant neoplasm to brain
Item
brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to 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])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0038317 (UMLS CUI [6])
C1274136 (UMLS CUI [7,1])
C0220650 (UMLS CUI [7,2])
Heart Diseases | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Myocardial Infarction | Ventricular arrhythmia
Item
history of cardiac disease, unstable angina, symptomatic congestive heart failure (chf) (class ≥ ii per the new york heart associate [nyha] guidelines), myocardial infarction, or ventricular arrhythmia ≤ 6 months prior to cycle 1, day 1
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0085612 (UMLS CUI [6])
Artificial cardiac pacemaker | Automatic Implantable Cardioverter-Defibrillators
Item
implantable pacemaker or automatic implantable cardioverter defibrillator
boolean
C0030163 (UMLS CUI [1])
C0972395 (UMLS CUI [2])
Congenital long QT syndrome | Family history of long QT syndrome
Item
congenital long qt syndrome or family history of long qt syndrome
boolean
C1141890 (UMLS CUI [1])
C3839836 (UMLS CUI [2])
Uncontrolled hypertension
Item
current uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Pharmaceutical Preparations Changing Cardiac conduction | Digitalis preparation | Adrenergic beta-Antagonists | Calcium Channel Blockers | Pharmaceutical Preparations Causing Torsades de Pointes
Item
current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (tdp)
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0304520 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0040479 (UMLS CUI [5,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
current known active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Major surgery | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])