Breast CancerPhase 2NCT07455955
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
A Phase 2 study testing Standard antiemetic regimen or Olanzapine antiemetic regimen in people with Breast Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objectives of this study are to determine if pharmacogenetic (PG) analysis of an individual enable optimal selection of antiemetic regimen for patients undergoing the first cycle of AC (Adriamycin + Cyclophosphamide) or FEC (Fluorouracil + Epirubicin + Cyclophosphamide) chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard antiemetic regimen or Olanzapine antiemetic regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Mar 2026to 3 Jul 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese patient, female >/=18 and < 75 years of age.
- Patient is diagnosed with early breast cancer.
- Patient is naïve to emetogenic chemotherapy moderately or highly emetogenicity.
- Patient is scheduled to receive her first course of neoadjuvant/adjuvant chemotherapy for breast cancer follows: AC: Intravenous (IV) Adriamycin 60 mg/m^2 + Cyclophosphamide 600 mg/m^2, given as 14-day cycle or 21-day cycle, or FEC: IV Fluorouracil 500 mg/m^2 + Epirubicin 100 mg/m^2 + Cyclophosphamide 500 mg/m^2, given as 21-day cycle
- Patient has a predicted life expectancy of >/= 4 months.
- Patient has ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1.
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- Premenopausal female patients must not be pregnant (documented negative urine pregnancy test).
- Patient is able to read, understand and complete study questionnaires and diary, including questions requiring a visual analog scale (VAS) response.
- Patient understands the procedures and agrees to participate in the study by giving written informed consent.
Who cannot join
- Patient with advanced breast cancer.
- Patient receiving cisplatin or any other chemotherapy of higher emetogenic potential, except for cyclophosphamide and doxorubicin in the regimens described above.
- 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
- Patient has a history of treatment with moderately to highly emetogenic chemotherapy.
- Patient has an active infection (e.g., pneumonia, systemic fungal infection) or any uncontrolled disease (e.g., diabetes mellitus, hypertension) which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
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- Patient with history of glaucoma, dementia, seizures, Parkinson's disease, Neuroleptic Malignant Syndrome (NMS), thromboembolic events.
- Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
- Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- Patients who are regular alcohol drinker or smoker
- Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
- Patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone.
- Patients who have phenylketonuria and abnormal uric acid.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
Winnie YEO, MBBS, MD, FRCP, 3505 1042, winnie@clo.cuhk.edu.hk
Dong LAI, RN, 3505 1138, dong@clo.cuhk.edu.hk
About this study
Official title: Phase II Study of Personalized Antiemetic Regimen Based on Pharmacogenetic Profile for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients.
The objectives of this study are to determine if pharmacogenetic (PG) analysis of an individual enable optimal selection of antiemetic regimen for patients undergoing the first cycle of AC (Adriamycin + Cyclophosphamide) or FEC (Fluorouracil + Epirubicin + Cyclophosphamide) chemotherapy. It also aims to compare the quality of life of patients in the first cycle of AC / FEC chemotherapy with PG analysis.
Patients enrolled into this study will be named as "Upfront-PG patients". Outcomes of the Upfront-PG patients in this prospective study will be compared to a historical control group (i.e. the "Non-upfront-PG patients"). The historical control group comprised of patients who were enrolled into a prior study. The latter did not have upfront PG analysis. These Non-upfront-PG patients received Standard antiemetic regimen, with PG analysis performed retrospectively as part of that prior study.
- Conditions
- Breast Cancer
- Being tested
- Standard antiemetic regimen or Olanzapine antiemetic regimen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard antiemetic regimen or Olanzapine antiemetic regimenDrug
Standard antiemetic regimen:
- Day 1: Aprepitant 125mg QD (once daily); Ondansetron 8mg BD (twice daily); Dexamethasone 12mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1)
- Days 2 to 3: Aprepitant 80mg QD
Olanzapine antiemetic regimen:
- Day 1: Aprepitant 125mg QD; Ondansetron 8mg BD; Dexamethasone 12 mg QD; Olanzapine 10mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1); Olanzapine 10mg nocte
- Days 2 to 3: Aprepitant 80mg QD; Olanzapine 10mg nocte
- Days 4-5: Olanzapine 10mg nocte
| Study group | Role | What they receive |
|---|---|---|
| Upfront PG group | Experimental | In Upfront PG group, there are 4 PG subgroups:
* Subgroup A: Standard antiemetic regimen will be given.
* Subgroup B: Standard antiemetic regimen will be given.
* Subgroup C: Olanzapine antiemetic regimen will be given.
* Subgroup D: Olanzapine antiemetic regimen will be given. Receives: Drug: Standard antiemetic regimen or Olanzapine antiemetic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Protection (CP)
CP was defined as no vomiting, no use of rescue therapy and 'no significant nausea' (NSN) during the study periods. NSN is defined as a nausea VAS of <25 mm.
Measured: 2 years
Secondary outcomes (1)
No Nausea (NN)
NN is defined as a nausea VAS of <5 mm.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start31 Mar 2026
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winnie Yeo, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455955
- Sponsor's protocol ID
- SYM014
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Personalized Antiemetic Regimen Based on Pharmacogenetic Profile for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT07455955
- Acronym / sponsor ID
- SYM014
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
The objectives of this study are to determine if pharmacogenetic (PG) analysis of an individual enable optimal selection of antiemetic regimen for patients undergoing the first cycle of AC (Adriamycin + Cyclophosphamide) or FEC (Fluorouracil + Epirubicin + Cyclophosphamide) chemotherapy. It also aims to compare the quality of life of patients in the first cycle of AC / FEC chemotherapy with PG analysis.
Patients enrolled into this study will be named as "Upfront-PG patients". Outcomes of the Upfront-PG patients in this prospective study will be compared to a historical control group (i.e. the "Non-upfront-PG patients"). The historical control group comprised of patients who were enrolled into a prior study. The latter did not have upfront PG analysis. These Non-upfront-PG patients received Standard antiemetic regimen, with PG analysis performed retrospectively as part of that prior study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upfront PG group | Experimental | Drug: Standard antiemetic regimen or Olanzapine antiemetic regimenIn Upfront PG group, there are 4 PG subgroups: * Subgroup A: Standard antiemetic regimen will be given. * Subgroup B: Standard antiemetic regimen will be given. * Subgroup C: Olanzapine antiemetic regimen will be given. * Subgroup D: Olanzapine antiemetic regimen will be given. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chinese patient, female >/=18 and < 75 years of age.
- Patient is diagnosed with early breast cancer.
- Patient is naïve to emetogenic chemotherapy moderately or highly emetogenicity.
- Patient is scheduled to receive her first course of neoadjuvant/adjuvant chemotherapy for breast cancer follows: AC: Intravenous (IV) Adriamycin 60 mg/m^2 + Cyclophosphamide 600 mg/m^2, given as 14-day cycle or 21-day cycle, or FEC: IV Fluorouracil 500 mg/m^2 + Epirubicin 100 mg/m^2 + Cyclophosphamide 500 mg/m^2, given as 21-day cycle
- Patient has a predicted life expectancy of >/= 4 months.
Key exclusion criteria (14 listed)
- Patient with advanced breast cancer.
- Patient receiving cisplatin or any other chemotherapy of higher emetogenic potential, except for cyclophosphamide and doxorubicin in the regimens described above.
- 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
- Patient has a history of treatment with moderately to highly emetogenic chemotherapy.
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 |
|---|---|---|
| Standard antiemetic regimen or Olanzapine antiemetic regimenStandard antiemetic regimen: * Day 1: Aprepitant 125mg QD (once daily); Ondansetron 8mg BD (twice daily); Dexamethasone 12mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1) * Days 2 to 3: Aprepitant 80mg QD Olanzapine antiemetic regimen: * Day 1: Aprepitant 125mg QD; Ondansetron 8mg BD; Dexamethasone 12 mg QD; Olanzapine 10mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1); Olanzapine 10mg nocte * Days 2 to 3: Aprepitant 80mg QD; Olanzapine 10mg nocte * Days 4-5: Olanzapine 10mg nocte | Drug | Upfront PG group |
Primary outcome
Complete Protection (CP)
Time frame: 2 years
CP was defined as no vomiting, no use of rescue therapy and 'no significant nausea' (NSN) during the study periods. NSN is defined as a nausea VAS of <25 mm.
1 secondary outcome
No Nausea (NN)
Time frame: 2 years
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Standard antiemetic regimen or Olanzapine antiemetic regimen 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Oct 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?
Contact Winnie YEO, MBBS, MD, FRCP (3505 1042, winnie@clo.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Protection (CP) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.