Gene test could personalize Anti-Nausea treatment for breast cancer chemo
NCT ID NCT07455955
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a genetic test can help doctors choose the best anti-nausea drugs for Chinese women with early breast cancer undergoing chemotherapy. About 200 participants will either receive standard anti-nausea medication or a personalized regimen based on their genetic profile. The goal is to see if the personalized approach reduces vomiting and nausea and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Standard antiemetic regimen (aprepitant, ondansetron, dexamethasone) with or without olanzapine
- What this could lead to
- If successful, this could lead to a personalized approach to prevent chemotherapy-induced nausea and vomiting, improving comfort and quality of life for breast cancer patients.
- What could go wrong
- This is a small, early-phase study (Phase 2) with only 200 Chinese breast cancer patients, so results may not apply to other groups. The genetic test may not reliably predict which antiemetic works best, and olanzapine can cause side effects like drowsiness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 74 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Clinical Oncology, Prince of Wales Hospital
RECRUITINGHong Kong, Hong Kong
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria supplement tested against chemo hair loss
- Can a mindfulness program boost Self-Compassion in breast cancer survivors?
- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?