Gender | Racial group | Estrogen receptor positive status [ER+] Breast Carcinoma | Tumor Stage Classification | Neoadjuvant Therapy
Item
females of all races with clinical stage i, ii, or iii er-positive breast cancer who qualify for standard neoadjuvant treatment
boolean
C0079399 (UMLS CUI [1])
C0034510 (UMLS CUI [2])
C1719706 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0178759 (UMLS CUI [4])
C0600558 (UMLS CUI [5])
Age
Item
age 18 years and older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cell (wbc) count ≥ 3,000/mm3 within 2 weeks prior to registration.
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
boolean
C0032181 (UMLS CUI [1])
SGOT - Glutamate oxaloacetate transaminase | Upper Limit of Normal
Item
serum glutamic-oxaloacetic transaminase (sgot) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
boolean
C0242192 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
Aspartate aminotransferase measurement | Upper Limit of Normal
Item
aspartate aminotransferase test (ast) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
boolean
C0201899 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
Bilirubin, total measurement | Upper Limit of Normal
Item
bilirubin ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
boolean
C0201913 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
boolean
C0201976 (UMLS CUI [1])
Informed Consent Institutional Review Board Approval
Item
must sign an informed consent approved by the uams institutional review board (irb).
boolean
C0021430 (UMLS CUI [1,1])
C2346499 (UMLS CUI [1,2])
Communicable Diseases Requirement Antibiotic therapy
Item
active infection requiring treatment with antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
Organic brain syndrome | Study Subject Participation Status Limited
Item
diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
boolean
C0029221 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Impaired cognition | Study Subject Participation Status Limited
Item
diagnosis or evidence of significant impairment of basal cognitive function that might preclude participation in the full protocol.
boolean
C0338656 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Malignant Neoplasms | In situ cancer | Lobular carcinoma in situ of breast | Carcinoma in situ of uterine cervix | Atypical melanocytic hyperplasia | Clark melanoma level 1 | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
no other current malignancies. subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or clark i melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
boolean
C0006826 (UMLS CUI [1])
C0851135 (UMLS CUI [2])
C0279563 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C1265952 (UMLS CUI [5])
C0205598 (UMLS CUI [6])
C0007117 (UMLS CUI [7])
C0553723 (UMLS CUI [8])
Autoimmune Diseases | Immune System and Related Disorders | Therapeutic procedure | Adrenal Cortex Hormones | Prednisone | Dexamethasone | Antiemetics | Steroid Cream
Item
autoimmune disorders or conditions of immunosuppression. this includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. replacement doses of steroids for subjects with adrenal insufficiency are allowed.
boolean
C0004364 (UMLS CUI [1])
C1334156 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
C0011777 (UMLS CUI [6])
C0003297 (UMLS CUI [7])
C2985380 (UMLS CUI [8])
Pregnancy | Breast Feeding | Vaccines, Peptide | Childbearing Potential Urine pregnancy test negative Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraception, Barrier | Intrauterine Devices
Item
pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study drug and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. accepted methods of contraception include oral contraceptives, barrier methods, iuds, and abstinence.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0599934 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
Other medical condition | Mental disorders | Compliance behavior Limited
Item
any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.
boolean
C3843040 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])