Status:
ACTIVE_NOT_RECRUITING
AKY15-HK-301_NEPA Study
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Princess Margaret Hospital, Hong Kong
Conditions:
Breast Cancer
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
Nausea and vomiting (feeling sick to your stomach and throwing up) are two of the most common unpleasant side effects of chemotherapy agents (drugs specifically used to treat cancer) that will be used...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03386617
Start Date
February 27 2018
End Date
December 31 2026
Last Update
December 12 2024
Active Locations (1)
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1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong