Breast adenocarcinoma Invasive Primary TNM clinical staging | Tumor size
Item
histologically confirmed primary invasive adenocarcinoma of the breast , t2-3, n0-3, m0, with tumor size of ≥ 2 cm
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0475440 (UMLS CUI [2])
Breast adenocarcinoma Early stage | Enrollment Independent of Receptor status
Item
all patients with early stage breast adenocarcinoma may enroll irrespective of receptor status
boolean
C0858252 (UMLS CUI [1,1])
C2363430 (UMLS CUI [1,2])
C1516879 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0449443 (UMLS CUI [2,3])
Breast Carcinoma untreated | Exception Therapeutic procedure Noninfiltrating Intraductal Carcinoma
Item
no prior treatment for breast cancer excluding therapy for dcis
boolean
C0678222 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0007124 (UMLS CUI [2,3])
Karnofsky Performance Status
Item
karnofsky performance status of 80 - 100
boolean
C0206065 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA
Item
left ventricular ejection fraction (lvef) ≥ 50% by echocardiogram or multiple gated acquisition (muga)
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable | Investigational New Drugs
Item
women of child-bearing potential (wocbp) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Inflammatory Breast Carcinoma | Secondary malignant neoplasm of female breast
Item
inflammatory or metastatic breast cancer
boolean
C0278601 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Patient unfit for Operation on breast | Patient unfit for Operative Surgical Procedure Axillary
Item
unfit for breast and/or axillary surgery
boolean
C3839996 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
C3839996 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
Sensory neuropathy | Motor neuropathy
Item
evidence of baseline sensory or motor neuropathy
boolean
C0151313 (UMLS CUI [1])
C0235025 (UMLS CUI [2])
Cardiovascular Disease | Comorbidity Serious | Communicable Disease Serious | HIV Infection
Item
significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (hiv) infection
boolean
C0007222 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
Anthracyclines | Hypersensitivity Investigational New Drugs | Hypersensitivity Cremophor EL
Item
history of prior anthracycline therapy allergies to any study medication or cremophor® el
boolean
C0282564 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0056476 (UMLS CUI [3,2])