Breast adenocarcinoma Invasive | Breast Carcinoma Resectable TNM Breast tumor staging
Item
all study patients must have histologically confirmed invasive adenocarcinoma of the breast. their breast cancer must be resectable clinical stage i or ii breast cancer as defined by the current ajcc tnm staging system (greene fl, page dl, fleming id, et al.: editors. ajcc cancer staging manual, 6th edition. new york: springer; 2002).
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
Informed Consent
Item
all patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.
boolean
C0021430 (UMLS CUI [1])
Age
Item
all subjects must be age >18 years.
boolean
C0001779 (UMLS CUI [1])
Liver function | Renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
all subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (ast or alt) ≤ 1.5 times the upper limits of normal, total bilirubin ≤ 1.5 times the upper limits of normal, serum creatinine ≤
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Creatinine clearance Estimated
Item
1.5 times the upper limit of normal or ecrcl ≥ 60 ml/min.
boolean
C0151280 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Therapeutic radiology procedure Breast Carcinoma
Item
patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.
boolean
C1522449 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma
Item
patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Female Sterilization | Postmenopausal state | Childbearing Potential Contraceptive methods | Oral contraception | Contraceptive implant | Hormonal contraception Injectable | Intrauterine Devices | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides | Sexual Abstinence | Partner had vasectomy | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0029151 (UMLS CUI [4])
C1657106 (UMLS CUI [5])
C2985296 (UMLS CUI [6,1])
C0086466 (UMLS CUI [6,2])
C0021900 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0221829 (UMLS CUI [10])
C0087145 (UMLS CUI [11])
C0036899 (UMLS CUI [12])
C0420842 (UMLS CUI [13])
C3831118 (UMLS CUI [14,1])
C0430061 (UMLS CUI [14,2])
C3831118 (UMLS CUI [15,1])
C0430057 (UMLS CUI [15,2])
C0032961 (UMLS CUI [16])
C0006147 (UMLS CUI [17])
C3831118 (UMLS CUI [18,1])
C0700589 (UMLS CUI [18,2])
C0332197 (UMLS CUI [18,3])
Abnormality of the gastrointestinal tract | Lacking Able to take medication Oral | Requirement Intravenous Feeding | Surgery Affecting Nutrient absorption | Surgery Affecting Drug absorption
Item
patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.
boolean
C4023588 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C4075001 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0021910 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1961155 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0678745 (UMLS CUI [5,3])
Disease Serious Uncontrolled | Investigational Therapy Impaired | Communicable Disease Impairing Investigational Therapy | Heart Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious | Dementia Preventing Informed Consent | MENTAL STATUS ALTERED Preventing Informed Consent | Dementia Preventing Protocol Compliance | MENTAL STATUS ALTERED Preventing Protocol Compliance
Item
a serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0949266 (UMLS CUI [3,3])
C0018799 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0003811 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0497327 (UMLS CUI [10,1])
C1292733 (UMLS CUI [10,2])
C0021430 (UMLS CUI [10,3])
C0746533 (UMLS CUI [11,1])
C1292733 (UMLS CUI [11,2])
C0021430 (UMLS CUI [11,3])
C0497327 (UMLS CUI [12,1])
C1292733 (UMLS CUI [12,2])
C0525058 (UMLS CUI [12,3])
C0746533 (UMLS CUI [13,1])
C1292733 (UMLS CUI [13,2])
C0525058 (UMLS CUI [13,3])