AKY15-HK-301_NEPA Study

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Chinese University of Hong Kong
Updated on 27 February 2022
cancer treatment
adjuvant chemotherapy


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 for cancer treatment. If nausea and vomiting are not controlled, they could lead to dehydration, poor nutrition and a longer time in the hospital. Nausea and vomiting usually occur in response to conditions that affect the gut and the vomiting center, which is an area in the brain.

Netupitant and palonosetron are drugs that are thought to block the activation of certain types of chemicals in these areas (brain and gut) and, therefore, to prevent or reduce the severity of nausea and vomiting. Nausea and vomiting caused by chemotherapy is classified into two patterns based on the time of onset or start. Acute nausea and vomiting start within 24 hours of chemotherapy administration. Delayed nausea and vomiting starts approximately 2-5 days after chemotherapy administration. Regardless of when the nausea and vomiting start, these symptoms are usually treated with not just one drug, but a combination of drugs. In this study you will receive the study drug, which is a fixed combination of netupitant and palonosetron.

This is an open label single arm study. The main purpose of this study or clinical trial is to learn more about the effect (how well it works) of the fixed combination of netupitant and palonosetron (NEPA) in preventing nausea and vomiting associated with chemotherapy in Hong Kong oncology patients receiving (neo)-adjuvant chemotherapy treatment consists of adriamycin and cyclophosphamide for breast cancer.

Condition Breast Cancer
Treatment NEPA
Clinical Study IdentifierNCT03386617
SponsorChinese University of Hong Kong
Last Modified on27 February 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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