Invasive carcinoma of breast
Item
1. patients with histologic confirmation of invasive breast carcinoma.
boolean
C0853879 (UMLS CUI [1])
Primary tumor Intact
Item
2. patients must have intact primary tumor.
boolean
C0677930 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Age
Item
3. ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
Bilateral breast cancer
Item
4. patients with bilateral breast cancer are eligible.
boolean
C0281267 (UMLS CUI [1])
Breast Carcinoma Primary second
Item
5. patients with second primary breast cancers are eligible.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
Breast Carcinoma Primary Size Physical Examination | Breast Carcinoma Primary Size Imaging
Item
6. the primary breast tumor must be ≥ 2 cm by physical exam or imaging.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C0678222 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C0011923 (UMLS CUI [2,4])
Neoplasm HER2 Negative
Item
7. the tumor must have been determined to be her2-negative as follows:
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
FISH Negative | HER2/CEP17 Ratio
Item
fluorescent in situ hybridization (fish)-negative (defined by ratio of her2 to cep17 must be < 2.2)
boolean
C0162789 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1977461 (UMLS CUI [2])
Immunohistochemistry
Item
immunohistochemistry (ihc) 0-1+; or
boolean
C0021044 (UMLS CUI [1])
Immunohistochemistry | FISH Negative
Item
ihc 2+ and fish-negative
boolean
C0021044 (UMLS CUI [1])
C0162789 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
ECOG performance status
Item
8. ecog ps of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum pregnancy test Repeated | Childbearing Potential Urine pregnancy test Repeated | Childbearing Potential Contraceptive methods | Intrauterine Devices | Vaginal Spermicides | Contraception, Barrier | Hormonal contraception
Item
9. negative serum pregnancy test ≤7 days of treatment initiation and a serum or urine pregnancy test must be repeated ≤ 3 days prior to starting treatment for women of childbearing potential (wocbp). for wocbp, adequate contraception must be used throughout the study. for this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. women who are already on hormonal forms of birth control may continue that treatment but must also use a barrier method.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430064 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0021900 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C2985296 (UMLS CUI [8])
Comprehension Study Protocol | Informed Consent | Authorization Health information | Protocol Compliance
Item
10. ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0680281 (UMLS CUI [3,1])
C0850397 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4])
Biopsy of breast
Item
11. patient must be willing to undergo breast biopsies as required by the study protocol.
boolean
C0405352 (UMLS CUI [1])
Tissue specimen Sufficient Core needle biopsy | Other Coding
Item
12. sufficient tissue must be available from the diagnostic core biopsies. if not, patients must undergo additional biopsies to perform mammostrat.
boolean
C1292533 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Cancer Other Invasive Treated | Exception Skin carcinoma | Exception Cervical cancer Non-invasive
Item
1. patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C4048328 (UMLS CUI [3,2])
C0205303 (UMLS CUI [3,3])
Prior Therapy | Investigational New Drugs
Item
2. prior treatment with any investigational drug within the preceding 4 weeks.
boolean
C1514463 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Heart Disease New York Heart Association Classification
Item
3. evidence of new york heart association class iii or greater cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Cerebrovascular accident | Ventricular arrhythmia | Cardiac conduction abnormality Symptomatic
Item
4. history of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0085612 (UMLS CUI [3])
C1842820 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Comorbidity Severe | Comorbidity Uncontrolled | Sepsis | Diabetes Mellitus | Hypertensive disease | Coronary Artery Disease | Congestive heart failure | Major surgery | Comorbidity compromises Patient safety | Comorbidity compromises Completion of clinical trial
Item
5. concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure or major surgery) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0243026 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0020538 (UMLS CUI [5])
C1956346 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0679637 (UMLS CUI [8])
C0009488 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C1113679 (UMLS CUI [9,3])
C0009488 (UMLS CUI [10,1])
C2945640 (UMLS CUI [10,2])
C2732579 (UMLS CUI [10,3])
Pregnancy | Breast Feeding
Item
6. pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Allergic Reaction Cremophor | Allergic Reaction Chemicals Clinical Trial
Item
7. known allergic reaction to cremophor or any of the chemo agents on this trial.
boolean
C1527304 (UMLS CUI [1,1])
C0056475 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0220806 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])