Breast CancerPhase 2NCT03386617
AKY15-HK-301_NEPA Study
A Phase 2 study testing NEPA in people with Breast Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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 for cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- NEPA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Feb 2018to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Open Label Single Arm Study for NEPA [Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron] in Hong Kong Oncology Patients Receiving (Neo)-Adjuvant Chemotherapy Treatment Consists of Adriamycin and Cyclophosphamide for Breast Cancer
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.
- Conditions
- Breast Cancer
- Being tested
- NEPA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEPADrug
Day 1 of each chemotherapy cycle:
1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| NEPA | Experimental | Day 1 of each chemotherapy cycle:
1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded. Receives: Drug: NEPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the proportion of patients with a Complete Response (CR), during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary
Measured: up to 84 days
To evaluate the proportion of patients with Complete Protection during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary
Measured: up to 84 days
Secondary outcomes (10)
Complete Response during the acute (0-24 h) phase in Cycle 1 by using patient diary
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Response during the overall (0-120 h) phase in Cycle 1 by using patient diary
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Protection during the acute (0-24 h) phase in Cycle 1 by using patient diary
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Protection during the overall (0-120 h) phase in Cycle 1 by using patient diary
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during the acute delayed phase in cycle 1 will be summarized descriptively
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during overall phase in cycle 1 will be summarized descriptively
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Healthcare resources utilization; The number of hospitalizations will be summarized descriptively
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Evaluation of NEPA safety profile; Clinical evaluations for safety assessments will include monitoring AEs
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
To assess the impact of nausea and vomiting on patients' quality of life, the FILE (Functional Living Index-Emesis) with a 5-day recall will be used.
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
A total FLIE score (expressed in FLIE points) greater than 108 will be categorized as having no impact on daily life
Measured: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start27 Feb 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Winnie Yeo, MD, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386617
- Sponsor's protocol ID
- SYM011
- Status last verified
- Mar 2026
- First submitted
- 22 Nov 2017
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yeo W, Lau TK, Kwok CC, Lai KT, Chan VT, Li L, Chan V, Wong A, Soo WM, Yeung EW, Wong KH, Tang NL, Suen JJ, Mo FK. NEPA efficacy and tolerability during (neo)adjuvant breast cancer chemotherapy with cyclophosphamide and doxorubicin. BMJ Support Palliat Care. 2022 Jul;12(e2):e264-e270. doi: 10.1136/bmjspcare-2019-002037. Epub 2020 Jan 29.
PubMed 31996363
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Single Arm Study for NEPA [Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron] in Hong Kong Oncology Patients Receiving (Neo)-Adjuvant Chemotherapy Treatment Consists of Adriamycin and Cyclophosphamide for Breast Cancer
- ClinicalTrials.gov ID
- NCT03386617
- Acronym / sponsor ID
- SYM011
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEPA | Experimental | Drug: NEPADay 1 of each chemotherapy cycle: 1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEPADay 1 of each chemotherapy cycle: 1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded. | Drug | NEPA |
Primary outcome
To evaluate the proportion of patients with a Complete Response (CR), during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary
Time frame: up to 84 days
To evaluate the proportion of patients with Complete Protection during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary
Time frame: up to 84 days
10 secondary outcomes
Complete Response during the acute (0-24 h) phase in Cycle 1 by using patient diary
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Response during the overall (0-120 h) phase in Cycle 1 by using patient diary
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Protection during the acute (0-24 h) phase in Cycle 1 by using patient diary
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Protection during the overall (0-120 h) phase in Cycle 1 by using patient diary
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during the acute delayed phase in cycle 1 will be summarized descriptively
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during overall phase in cycle 1 will be summarized descriptively
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Healthcare resources utilization; The number of hospitalizations will be summarized descriptively
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Evaluation of NEPA safety profile; Clinical evaluations for safety assessments will include monitoring AEs
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
To assess the impact of nausea and vomiting on patients' quality of life, the FILE (Functional Living Index-Emesis) with a 5-day recall will be used.
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
A total FLIE score (expressed in FLIE points) greater than 108 will be categorized as having no impact on daily life
Time frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Derived from this study: PubMed 31996363Yeo W, Lau TK, Kwok CC, Lai KT, Chan VT, Li L, Chan V, Wong A, Soo WM, Yeung EW, Wong KH, Tang NL, Suen JJ, Mo FK. NEPA efficacy and tolerability during (neo)adjuvant breast cancer chemotherapy with cyclophosphamide and doxorubicin. BMJ Support Palliat Care. 2022 Jul;12(e2):e264-e270. doi: 10.1136/bmjspcare-2019-002037. Epub 2020 Jan 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winnie Yeo, MD, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NEPA in people with Breast Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the proportion of patients with a Complete Response (CR), during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary (time frame: up to 84 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03386617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.