Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile (NCT07455955) | Clinical Trial Compass
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Hong Kong200 participantsStarted 2026-03-31
Plain-language 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. 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.
Who can participate
Age range
18 Years – 74 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 E…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.