Clinical Trial Details
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NCT03386617 : AKY15-HK-301_NEPA Study
PhasePhase 2
AgesMin: 18 Years Max: 74 Years
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

- 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

- 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
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