Invasive carcinoma of breast | Disease TNM clinical staging | Neoplasm Metastasis Physical Examination | Neoplasm Metastasis Radiology studies
Item
histologically confirmed invasive breast cancer with stage iv disease, according to ajcc 6th edition, either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study
boolean
C0853879 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0807679 (UMLS CUI [4,2])
Triple-Negative Breast Cancer
Item
all tumors must be er-, pgr- and her2-negative
boolean
C2348819 (UMLS CUI [1])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Paraffin Embedded Tissue Primary tumor Requirement | Paraffin Embedded Tissue Biopsy Neoplasm Metastasis | Timepoint Relapse
Item
paraffin tissue block is required from the primary tumor tissue or from diagnostic metastatic biopsy at time of relapse
boolean
C1519524 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1519524 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C2348792 (UMLS CUI [3,1])
C0035020 (UMLS CUI [3,2])
Measurable Disease
Item
measurable disease by recist
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
performance status of 0,1 or 2 by ecog criteria
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
normal organ and bone marrow function documented within 14 days prior to enrollment as defined by the protocol
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Chemotherapy Quantity Breast cancer recurrent | Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
more than 1 prior chemotherapy for the treatment of recurrent or metastatic breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278493 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0346993 (UMLS CUI [2,3])
Cisplatin | Carboplatin | Chemotherapeutic Agents Platinum
Item
prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents
boolean
C0008838 (UMLS CUI [1])
C0079083 (UMLS CUI [2])
C0003392 (UMLS CUI [3,1])
C0032207 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain | Neurologic Symptoms Suggestive of Metastatic malignant neoplasm to brain
Item
active brain metastases or unevaluated neurological symptoms suggestive of brain metastases
boolean
C0220650 (UMLS CUI [1])
C0235031 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0220650 (UMLS CUI [2,3])
Comorbidity Affecting Study Subject Participation Status | Other medical condition Major Affecting Study Subject Participation Status
Item
intercurrent illness or other major medical condition or comorbid condition that might affect study participation
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Heart Disease Uncontrolled | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Congestive heart failure Uncontrolled | Cardiomyopathy Symptomatic | Cardiomyopathy Asymptomatic | Ejection fraction decreased
Item
significant history of uncontrolled cardiac disease such as uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased ejection fraction <45%
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0878544 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C0878544 (UMLS CUI [7,1])
C0231221 (UMLS CUI [7,2])
C0743400 (UMLS CUI [8])
Renal dysfunction | Cisplatin Requirement Dose Modification | Cisplatin Dose Uncertain
Item
renal dysfunction for which cisplatin dose would either require dose modification or would be considered unsafe
boolean
C3279454 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
C0008838 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0087130 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Curative treatment Absent
Item
history or other malignancy that was not treated with curative intent
boolean
C0006826 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])