Triple Negative Breast Neoplasm Invasive
Item
histologically confirmed diagnosis of invasive triple negative breast cancer
boolean
C3539878 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
LCL161 | Gene Expression Signature predictive
Item
known status for the lcl161 predictive gene expression signature as determined during molecular pre-screening
boolean
C2984020 (UMLS CUI [1])
C0017262 (UMLS CUI [2,1])
C1708225 (UMLS CUI [2,2])
C0681890 (UMLS CUI [2,3])
Patients Appropriate Mastectomy | Patients Appropriate Breast-Conserving Surgery
Item
candidates for mastectomy or breast-conserving surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0024881 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0917927 (UMLS CUI [2,3])
Primary tumor Diameter Imaging
Item
primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous amendment #3 was tumor size greater than 10 mm)
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Regional lymph nodes TNM clinical staging
Item
regional nodes n0-n2
boolean
C1179441 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Distant metastasis Absent
Item
absence of distant metastatic disease
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function
Item
adequate bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Liver function | Transaminase Assay
Item
adequate liver function and serum transaminases
boolean
C0232741 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Bilateral breast cancer | Inflammatory Breast Carcinoma | Bilateral mammography Required | Breast cancer recurrent Locally
Item
bilateral or inflammatory breast cancer (bilateral mammography is required during screening/baseline); locally recurrent breast cancer
boolean
C0281267 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
C0203027 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0278493 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
Systemic therapy Cancer Other | Systemic therapy Recent Malignant Neoplasm
Item
patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months
boolean
C1515119 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Heart Disease Uncontrolled
Item
uncontrolled cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Adrenal Cortex Hormones Dose per day chronic | Prednisone Dose | Glucocorticoids Equivalent | Inhaled steroids allowed | Topical steroids allowed | Therapeutic immunosuppression chronic
Item
patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C2064827 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0021079 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
Abnormal digestive tract function Affecting Absorption LCL161
Item
impaired gi function that may affect the absorption of lcl161
boolean
C0232459 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C2984020 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Exception Use of Contraceptive methods
Item
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])