Personalized anti-nausea treatment based on your genetic profile.
Randomized 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.
This trial will test if using a patient's genetic profile to choose anti-nausea medicines helps women with early breast cancer during their first AC or FEC chemotherapy cycle.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy, radiation, Cyclophosphamide, doxorubicin |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07455955 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 2 trial enrolls Chinese women with early breast cancer who are starting their first cycle of AC or FEC chemotherapy and randomizes them to pharmacogenetic (PG) testing versus no PG testing. Patients in the PG arm receive antiemetic prophylaxis tailored to their genetic results, including the option to add olanzapine when indicated, while the control arm receives current standard antiemetic prophylaxis. The study collects patient-reported nausea, vomiting, and quality-of-life measures during the first chemotherapy cycle to compare outcomes between groups. The primary aim is to see if genotype-guided antiemetic choice improves symptom control and quality of life.
Who should consider this trial
Good fit: Chinese women aged 18–74 with early breast cancer, ECOG 0–1, who are chemotherapy-naïve for moderately or highly emetogenic regimens and scheduled for their first AC or FEC cycle.
Not a fit: Patients who have already received emetogenic chemotherapy, who are receiving different chemotherapy regimens, who are pregnant, or who do not meet the age or ethnicity criteria are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, genotype-guided antiemetic selection could reduce nausea and vomiting and improve quality of life during the first cycle of AC/FEC chemotherapy.
How similar studies have performed: Prior research has shown genetic variants (for example CYP2D6) may influence antiemetic drug response, but pharmacogenetic-guided antiemetic strategies have limited validation and are not yet standard practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 50 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. * 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. Exclusion Criteria: * 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. * 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.
Where this trial is running
Hong Kong
- Department of Clinical Oncology, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Winnie YEO, MBBS, MD, FRCP
- Email: winnie@clo.cuhk.edu.hk
- Phone: 3505 1042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.