Invasive breast carcinoma | Primary tumor site Biopsy | Primary tumor site Surgery specialty
Item
1. the patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage i to iii
boolean
C0853879 (UMLS CUI [1])
C0475447 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0475447 (UMLS CUI [3,1])
C0038894 (UMLS CUI [3,2])
Primary tumor size
Item
2. the clinical or radiologic primary tumor size is at least 1.5 cm diameter
boolean
C1302656 (UMLS CUI [1])
Triple-Negative Breast Cancer Finding | Immunohistochemistry Score | Gene Dosage
Item
3. the patient was proven to have tnbc, defined from standard pathologic assays as negative for er and pr (<10% tumor staining) and negative for her2 (ihc score <3, gene copy number not amplified).
boolean
C2348819 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0178655 (UMLS CUI [3])
Tumor tissue sample | Neoadjuvant Therapy | Genomic Biomarker
Item
4. primary tumor sample was collected before nact began and was evaluated for genomic testing (integral biomarker). this allows patients who participate in 2011-0007 to be eligible for study participation.
boolean
C0475358 (UMLS CUI [1])
C0600558 (UMLS CUI [2])
C2348747 (UMLS CUI [3])
Age
Item
5. patients must be >18 years of age
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiogram
Item
6. patients must have lvef > 50% by muga or echo within 4 weeks prior to registration.
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C2243117 (UMLS CUI [3])
body system or organ function | Bone Marrow Function
Item
7. 3.1.7 patients must have adequate organ and marrow function as defined below: •
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
leukocytes >3,000/mcl • absolute neutrophil count >1,500/mcl • platelets >100,000/mcl
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Bilirubin, total measurement | SGOT - Glutamate oxaloacetate transaminase | SGPT - Glutamate pyruvate transaminase | Upper Limit of Normal | Creatinine measurement, serum | Creatinine clearance measurement
Item
• total bilirubin within normal institutional limits • ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal • creatinine within normal institutional limits or • creatinine clearance >60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
boolean
C0201913 (UMLS CUI [1])
C0242192 (UMLS CUI [2])
C0376147 (UMLS CUI [3])
C1519815 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
Disease Stage level 4
Item
1. the patient has diagnosis of stage iv disease or is found to have stage iv disease prior to randomization.
boolean
C0012634 (UMLS CUI [1,1])
C0441772 (UMLS CUI [1,2])
invasive cancer | Neoplasm Metastasis | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
2. prior history of invasive cancer within 5 years of study entry or history of metastatic cancer. exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skin.
boolean
C0677898 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0553723 (UMLS CUI [4])
Excision biopsy Invasive breast carcinoma
Item
3. prior excisional biopsy of the primary invasive breast cancer.
boolean
C0184921 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
Hematoma | Biopsy site Changing | primary tumor Diagnostic Imaging
Item
4. patients with hematomas or biopsy site changes that limit response assessment of the primary tumor by diagnostic imaging.
boolean
C0018944 (UMLS CUI [1])
C1301128 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
Chemotherapy Regimen taxane | Chemotherapy Regimen Anthracycline Antibiotics
Item
5. patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens.
boolean
C0392920 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0003234 (UMLS CUI [2,2])
Prior Therapy Anthracycline Antibiotics
Item
6. prior therapy with anthracyclines.
boolean
C1514463 (UMLS CUI [1,1])
C0003234 (UMLS CUI [1,2])
Neuropathy
Item
7. grade ii or higher neuropathy.
boolean
C0442874 (UMLS CUI [1])
Zubrod Performance Status
Item
8. patients with zubrod performance status of >2.
boolean
C3714786 (UMLS CUI [1])
cardiac event | Heart failure | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
9. patients with history of serious cardiac events defined as: • patients with a history of new york heart association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or cva within 6 months of protocol registration. •
boolean
C0741923 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Prolonged PR interval | Atrioventricular Block
Item
patients who have history of pr prolongation (grade 2 or higher) or av block.
boolean
C0600125 (UMLS CUI [1])
C0004245 (UMLS CUI [2])