Breast Carcinoma Localized | Locally advanced breast cancer | Chemotherapy cycle Quantity TC | docetaxel | Cyclophosphamide
Item
must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard tc (docetaxel 75 mg/m^2 and cyclophosphamide 600mg/m^2)
boolean
C0678222 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C4522122 (UMLS CUI [3,3])
C0246415 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
Age
Item
age >/= 65 years (senior adult focused study given increased risk for toxicity)
boolean
C0001779 (UMLS CUI [1])
Gender
Item
participants must be female
boolean
C0079399 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status <2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absence Neuropathy Pre-existing CTCAE Grades
Item
no pre-existing neuropathy grade > 1 per the nci common toxicity criteria for adverse effects (ctcae) version 4.0
boolean
C0332197 (UMLS CUI [1,1])
C0442874 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
Postmenopausal state | Amenorrhea Duration
Item
be postmenopausal (defined as amenorrheic for at least 12 months)
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Informed Consent
Item
must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with institutional guidelines and good clinical practice (gcp) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Illness Uncontrolled Limiting Protocol Compliance | Communicable Disease | Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia
Item
have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
Mental disorders Limiting Protocol Compliance
Item
have psychiatric illness that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Allergic Reaction Compound Taxanes Similar | Allergic Reaction Docetaxel | Paclitaxel allergy | Allergic Reaction Compound Cyclophosphamide Similar
Item
have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0796419 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0570707 (UMLS CUI [3])
C1527304 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C0010583 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
HIV Seropositivity | Hepatitis C virus Seropositive | Hepatitis B Surface Antigens Seropositive | Syphilis
Item
have known seropositivity for human immunodeficiency virus, hepatitis c virus, hepatitis b surface antigen, or syphilis. does not require serologic confirmation as a study procedure.
boolean
C0019699 (UMLS CUI [1])
C0220847 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0039128 (UMLS CUI [4])
Protocol Compliance Unwilling | Informed Consent Unwilling
Item
not willing to follow protocol requirements or to give informed consent
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])