Actively Recruiting
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Led by Chinese University of Hong Kong · Updated on 2026-04-01
200
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 and without PG analysis. Patients will be randomized to undergo PG analysis \[PG group\] versus no PG analysis \[Non-/+PG group\]. Those in the PG group would be offered currently available optimal antiemetic prophylaxis, with or without Olanzapine according to PG outcomes. Those in the Non-PG group would be offered currently available optimal antiemetic prophylaxis.
CONDITIONS
Official Title
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese female patient aged 18 to less than 75 years
- Diagnosed with early breast cancer
- Never received moderately or highly emetogenic chemotherapy
- Scheduled for first cycle of neoadjuvant or adjuvant chemotherapy with AC or FEC regimen
- Predicted life expectancy of at least 4 months
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Premenopausal women must have a documented negative pregnancy test
- Able to read, understand, and complete study questionnaires and diary including visual analog scale responses
- Understands study procedures and provides written informed consent
You will not qualify if you...
- Advanced breast cancer diagnosis
- Receiving cisplatin or chemotherapy with higher emetogenic potential than specified regimens
- Scheduled for concurrent radiation therapy with chemotherapy
- Experienced vomiting or moderate to severe nausea within 24 hours before chemotherapy start
- Received moderately to highly emetogenic chemotherapy previously
- Active infection or uncontrolled diseases that may affect study results or safety
- History of glaucoma, dementia, seizures, Parkinson's disease, Neuroleptic Malignant Syndrome, or thromboembolic events
- Current use of illicit drugs or evidence of alcohol abuse
- Mental incapacity or significant emotional/psychiatric disorder
- Regular alcohol drinking or smoking
- Any illness posing risk or affecting study results
- Hypersensitivity to aprepitant, ondansetron, or dexamethasone
- Phenylketonuria or abnormal uric acid levels
- Use of investigational drugs within 4 weeks prior to study or planned during study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
W
Winnie YEO, MBBS, MD, FRCP
CONTACT
D
Dong LAI, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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