Age | Locally advanced breast cancer | Inflammatory Breast Carcinoma | Core needle biopsy | Fine needle aspiration biopsy
Item
women or men > 18 years old with histologically confirmed, by needle core biopsy (not fna), locally advanced or inflammatory breast cancer.
boolean
C0001779 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
C1318309 (UMLS CUI [4])
C1510483 (UMLS CUI [5])
TNM clinical staging | Mastectomy | Breast-Conserving Surgery | Inflammatory Breast Carcinoma | Lymph Node Involvement region supraclavicular Ipsilateral | Measurable Disease | Lesion of breast size | Axillary lymph nodes Ipsilateral Fixed | Axillary lymph nodes Ipsilateral Marked | Internal mammary lymph nodes Ipsilateral
Item
all patients must have either t2 lesion which is felt to be initially resectable only through mastectomy by the surgeon, or with a t3 n0-n2; t4 any n; or any t with n2 or n3 clinical evidence of disease. stage 2 patients where breast conservation surgery is desired but impractical at diagnosis because of anticipated poor cosmetic outcome are eligible. patients with inflammatory breast carcinoma and women with ipsilateral supraclavicular node involvement are eligible. patients must have measurable disease defined as a breast lesion > 2 cm or with fixed or marked ipsilateral axillary nodes and/or ipsilateral internal mammary nodes.
boolean
C3258246 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0917927 (UMLS CUI [3])
C0278601 (UMLS CUI [4])
C0806692 (UMLS CUI [5,1])
C0446461 (UMLS CUI [5,2])
C0441989 (UMLS CUI [5,3])
C1513041 (UMLS CUI [6])
C0567489 (UMLS CUI [7,1])
C0456389 (UMLS CUI [7,2])
C0729594 (UMLS CUI [8,1])
C0441989 (UMLS CUI [8,2])
C3714578 (UMLS CUI [8,3])
C0729594 (UMLS CUI [9,1])
C0441989 (UMLS CUI [9,2])
C1706089 (UMLS CUI [9,3])
C0542554 (UMLS CUI [10,1])
C0441989 (UMLS CUI [10,2])
Premenopausal state | Postmenopausal state | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception Willing | Gender Oral Hormonal Contraceptives Willing
Item
pre-and post-menopausal female and male patients are eligible. women of childbearing potential must have a negative pregnancy test and, men and women must be willing to consent to using effective dual methods of contraception while on treatment and for three months thereafter.
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0009907 (UMLS CUI [5,2])
C0600109 (UMLS CUI [5,3])
Life Expectancy
Item
life expectancy of greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
Bone scan Chest Metastatic Neoplasm Negative | Bone scan Abdomen Metastatic Neoplasm Negative | Chest CT Metastatic Neoplasm Negative | CT Abdomen Metastatic Neoplasm Negative
Item
bone scan and cat scan of chest and abdomen negative for metastatic disease
boolean
C0203668 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C2939420 (UMLS CUI [1,3])
C0205160 (UMLS CUI [1,4])
C0203668 (UMLS CUI [2,1])
C0000726 (UMLS CUI [2,2])
C2939420 (UMLS CUI [2,3])
C0205160 (UMLS CUI [2,4])
C0202823 (UMLS CUI [3,1])
C2939420 (UMLS CUI [3,2])
C0205160 (UMLS CUI [3,3])
C0040405 (UMLS CUI [4,1])
C0000726 (UMLS CUI [4,2])
C2939420 (UMLS CUI [4,3])
C0205160 (UMLS CUI [4,4])
Metastatic Neoplasm
Item
patients with metastatic disease.
boolean
C2939420 (UMLS CUI [1])
Investigational New Drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Intercurrent disease Uncontrolled | Communicable Disease | Communicable Disease Continuous | Cellulitis Resolving Mild | Congestive heart failure Symptomatic | Angina, Unstable | Cardiac Arrhythmia Uncontrolled | Coronary Artery Disease | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection other than mild resolving cellulitis, symptomatic congestive heart failure (nyha > class 1), unstable angina pectoris, uncontrolled cardiac arrhythmia, known coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0277557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C0007642 (UMLS CUI [4,1])
C3714811 (UMLS CUI [4,2])
C2945599 (UMLS CUI [4,3])
C0018802 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0002965 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C1956346 (UMLS CUI [8])
C0004936 (UMLS CUI [9,1])
C1321605 (UMLS CUI [9,2])
C0439801 (UMLS CUI [9,3])
C0748872 (UMLS CUI [10,1])
C1321605 (UMLS CUI [10,2])
C0439801 (UMLS CUI [10,3])
Malignant Neoplasms | malignant neoplasm of breast TNM staging primary tumor | Skin carcinoma cured disease Surgical | Carcinoma in situ of uterine cervix cured disease Surgical
Item
cancer other than breast primary within the last 5 years with the exception of surgically cured non-melanoma skin cancer or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C2216708 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C0679252 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C0679252 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
Breast Feeding
Item
women who are breast-feeding.
boolean
C0006147 (UMLS CUI [1])