AKY15-HK-301_NEPA Study

Inclusion criteria

• Adult patients ( ≥ 18 and <75 years), female; a. Chinese patient, female ≥18 and < 75 years of age.
• Patient is diagnosed with early breast cancer.
• Patient is scheduled to receive her first course of (neo)- adjuvant chemotherapy for breast cancer follows:
• IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2
• ECOG Performance Status of 0-1;
• Written informed consent before study entry;
• If women of childbearing potential age: reliable contraceptive measures are to be used during all the planned course of the study;
• Ability and willingness of the patient to complete the diary and study questionnaires.

Exclusion criteria

• Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study;
• Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy;
• Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy;
• Patients who have taken any of the following agents within 7 calendar days prior to initiation of their chemotherapy regimen: 5-HT3 receptor antagonists, phenothiazines, benzamides, cannabinoids, NK1 receptor antagonists, corticosteroids, or benzodiazepines;
• Pregnant or breast-feeding women;
• Patient's inability to take oral medication;
• Gastrointestinal obstruction or active peptic ulcer;
• Psychiatric or CNS disorders interfering with ability to comply with study protocol;
• Patients at risk for severe cardiac/cardiovascular disorders
• Patients with myocardial infarction within 6 months