Breast Cancer
Conditions
Interventions
None listed
Sponsors
Laboratory of clinical pharmacology, Faculty of Pharmaceutical Sciences, Suzuka University of Medical Science
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Breast cancer patients 2) Over 20 years old 3) Patients who receive the first cycle of chemotherapy with AC (doxorubicin >= 50 mg/m2, cyclophosphamide >=500 mg/m2), EC (epirubicin >=75 mg/m2, cyclophosphamide >=500 mg/m2), or FEC (5-FU >=500 mg/m2, epirubicin >=75 mg/m2, cyclophosphamide >=500 mg/m2) regimen. 4) Informed consent by the document. 5) WBC >=3,000 /mm3, PLT >=75,000 /mm3 Hgb >=8.0 g/dL 6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 x upper limit of normal. Blood bilirubin <= 1.5 x upper limit of normal. 7) Creatinine <= 1.5 x upper limit of normal.
Exclusion criteria
Exclusion criteria: 1) Patients with some factors such as brain tumor, brain metastasis causing nausea and vomiting. 2) Received a CYP3A4 inducer (such as phenobarbital, phenytoin, carbamazepine, rifampicin and efavirenz) or inhibitor (such as clarithromycin, erythromycin, voriconazole, itraconazole and ritonavir) within 7 days before administration of anticancer drug. 3) Received a CYP2D6 inhibitor (terbinafine, fluvoxamine, paroxetine, escitalopram, duloxetine, cimetidine, quinidine) within 7 days before administration of anticancer drug. 4) Received a 5-HT3 receptor antagonist, D2 blocker or NK1 receptor antagonist within 7 days before administration of anticancer drug. 5) Received a radiation therapy within 14 days before administration of anticancer drug. 6) Hypersensitivity to therapeutic agent. 7) Patients who had been treated with one moderate of high emetogenic antitumour drug according to the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines. 8) Pregnant 9) Unstable glycemic control. 10) Patients judged ineligible by researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete response (defined as "no-emesis", and "no-rescue medication") in the overall phase (0-120 h after chemotherapy) | — |
Countries
Japan
Contacts
Public ContactSatoshi Yokoyama
Suzuka University of Medical Science Faculty of Pharmaceutical Sciences
Outcome results
None listed