Personalized anti-nausea treatment based on your genetic profile.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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.
* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.