Invasive carcinoma of breast Preoperative TNM Breast tumor staging | Clinical examination | Imaging Breast
Item
histologically or cytologically confirmed invasive breast cancer, pre-operative stages ii-iii per ajcc 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
boolean
C0853879 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C1456356 (UMLS CUI [2])
C0011923 (UMLS CUI [3,1])
C0006141 (UMLS CUI [3,2])
Residual Tumor Diameter Signs and Symptoms | Residual Tumor Diameter Radiography | Preoperative Chemotherapy
Item
cohort 1: at least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy
boolean
C0543478 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0543478 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C2347669 (UMLS CUI [3])
Preoperative Chemotherapy Absent | Disease Diameter Largest Signs and Symptoms | Disease Diameter Largest Radiography
Item
cohort 2: patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings
boolean
C2347669 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0443228 (UMLS CUI [2,3])
C0037088 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0443228 (UMLS CUI [3,3])
C0034571 (UMLS CUI [3,4])
Preoperative Chemotherapy Neoadjuvant Completed | Anthracyclines | taxane
Item
prior therapy for cohort 1 only: must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial
boolean
C2347669 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0282564 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
Neoplasms HER2/Neu Positive | Prior Therapy Quantity Trastuzumab | Trastuzumab Absent | Vaccination Absent
Item
her2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination
boolean
C0027651 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0728747 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hormone Therapy | Indication Hormone Therapy | Ovarian suppression | Vaccination
Item
must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations
boolean
C0279025 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0677922 (UMLS CUI [3])
C0042196 (UMLS CUI [4])
Primary tumor Excision Definitive Completed | Disease Gross Excision
Item
must have completed definitive resection of primary tumor with adequated excision of gross disease. surgery should have occured more than 28 days but within 12 weeks prior to enrollment
boolean
C0677930 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0443196 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
Hormone Therapy | Tamoxifen | Ovarian suppression | Aromatase Inhibitors
Item
may receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors
boolean
C0279025 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C0677922 (UMLS CUI [3])
C0593802 (UMLS CUI [4])
Neoplastic Cell Vaccination
Item
must have had prior banked tumor of sufficient cellular yield for vaccination
boolean
C0597032 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Immunotherapy | Glucocorticoids, Systemic
Item
greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
boolean
C0021083 (UMLS CUI [1])
C3540777 (UMLS CUI [2])
Operative Surgical Procedures Recent Patient recovered | Therapeutic radiology procedure Recent Patient recovered
Item
adequate recovery from recent surgery and radiation therapy
boolean
C0543467 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Communicable Disease Uncontrolled | Illness Uncontrolled
Item
uncontrolled active infection or illness
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Illness Protocol Compliance Limited | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
other medical or psychiatric illness or social situation that would limit study compliance
boolean
C0221423 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0748872 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnancy or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection
Item
evidence of hiv infection
boolean
C0019693 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Adenoviruses Based
Item
previous participation in an adenovirus-based trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0001483 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
Invasive cancer
Item
concurrent invasive malignancies
boolean
C0677898 (UMLS CUI [1])