Carcinoma of Male Breast Primary
Item
patients must have a histologically confirmed diagnosis of primary breast carcinoma
boolean
C0238033 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Chemotherapy naive
Item
patient must be naive to chemotherapy at the time of enrollment
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Adriamycin Intravenous Weekly | Doxorubicin Intravenous Weekly | Cyclophosphamide Oral Daily | Early-Stage Breast Carcinoma
Item
patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer
boolean
C0085752 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,3])
C0013089 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
C0010583 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
C2986665 (UMLS CUI [4])
Informed Consent
Item
the patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status
Item
patients must have a karnofsky index of greater than or equal to 50%
boolean
C0206065 (UMLS CUI [1])
Hepatic impairment Mild | Renal Insufficiency Mild | Cardiovascular impairment Mild | Hepatic impairment Moderate | Renal Insufficiency Moderate | Cardiovascular impairment Moderate
Item
known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
boolean
C0948807 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0848757 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C1565489 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C0848757 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
Investigational New Drugs
Item
receipt of investigational drug within 30 days before study entry
boolean
C0013230 (UMLS CUI [1])
Antiemetics | Chemotherapeutic Agents | Palonosetron Infusion solution | Dexamethasone Infusion solution | 5-HT>3< receptor antagonist | Dopamine Antagonists | Metoclopramide | phenothiazine | Prochlorperazine | Thiethylperazine | Perphenazine | Diphenhydramine | Scopolamine | Chlorpheniramine Maleate | trimethobenzamide | Hypersensitivity Taxane | Benzodiazepines | Haloperidol | Droperidol | Tetrahydrocannabinol | nabilone | CORTICOSTEROIDS FOR SYSTEMIC USE | Hydrocortisone | Methylprednisolone | Prednisone | Topical corticosteroids | inhaled steroids
Item
received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-ht3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)
boolean
C0003297 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
C0220578 (UMLS CUI [3,1])
C1272893 (UMLS CUI [3,2])
C0011777 (UMLS CUI [4,1])
C1272893 (UMLS CUI [4,2])
C0360055 (UMLS CUI [5])
C0242702 (UMLS CUI [6])
C0025853 (UMLS CUI [7])
C0031434 (UMLS CUI [8])
C0033229 (UMLS CUI [9])
C0039865 (UMLS CUI [10])
C0031184 (UMLS CUI [11])
C0012522 (UMLS CUI [12])
C0036442 (UMLS CUI [13])
C0546857 (UMLS CUI [14])
C0077163 (UMLS CUI [15])
C0020517 (UMLS CUI [16,1])
C0215136 (UMLS CUI [16,2])
C0005064 (UMLS CUI [17])
C0018546 (UMLS CUI [18])
C0013136 (UMLS CUI [19])
C0039663 (UMLS CUI [20])
C0068333 (UMLS CUI [21])
C3653708 (UMLS CUI [22])
C0020268 (UMLS CUI [23])
C0025815 (UMLS CUI [24])
C0032952 (UMLS CUI [25])
C0304604 (UMLS CUI [26])
C2065041 (UMLS CUI [27])
Vomiting | Retching | Nausea CTCAE Grades
Item
any vomiting, retching or nci common toxicity criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy
boolean
C0042963 (UMLS CUI [1])
C0232602 (UMLS CUI [2])
C0027497 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Vomiting Etiology Organ system
Item
ongoing vomiting from any organic etiology
boolean
C0042963 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0460002 (UMLS CUI [1,3])
CORTICOSTEROIDS FOR SYSTEMIC USE Patient need for | Chemotherapy | Prophylactic treatment Chemotherapy Toxicity | Topical form corticosteroids | inhaled steroids
Item
need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study
boolean
C3653708 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0199176 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0600688 (UMLS CUI [3,3])
C0304604 (UMLS CUI [4])
C2065041 (UMLS CUI [5])
Medical contraindication 5-HT>3< receptor antagonist | Medical contraindication palonosetron | Medical contraindication Dexamethasone
Item
known contraindication to 5-ht3 receptor antagonists (including palonosetron) or dexamethasone
boolean
C1301624 (UMLS CUI [1,1])
C0360055 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0220578 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0011777 (UMLS CUI [3,2])
Therapeutic radiology procedure Patient need for
Item
need to receive radiotherapy during the study
boolean
C1522449 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Protocol Compliance Unable
Item
inability to understand or cooperate with study procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])