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NCT Number: NCT07455955

Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile

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.

Recruiting

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Key information

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Dong LAI, RN

CONTACT

[email protected]

3505 1138

Winnie MM YEO, MBBS, MD, FRCP

PRINCIPAL_INVESTIGATOR

Winnie YEO, MBBS, MD, FRCP

CONTACT

[email protected]

3505 1042

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard antiemetic regimen or Olanzapine antiemetic regimen

Drug

Standard antiemetic regimen:

  • Day 1: Aprepitant 125mg QD (once daily); Ondansetron 8mg BD (twice daily); Dexamethasone 12mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1)
  • Days 2 to 3: Aprepitant 80mg QD

Olanzapine antiemetic regimen:

  • Day 1: Aprepitant 125mg QD; Ondansetron 8mg BD; Dexamethasone 12 mg QD; Olanzapine 10mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1); Olanzapine 10mg nocte
  • Days 2 to 3: Aprepitant 80mg QD; Olanzapine 10mg nocte
  • Days 4-5: Olanzapine 10mg nocte

Standard antiemetic regimen

Drug
  • Day 1: Aprepitant 125mg QD; Ondansetron 8mg BD; Dexamethasone 12mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1)
  • Days 2 to 3: Aprepitant 80mg QD

Primary outcomes

  1. Complete Protection (CP)

    Time frame: 2 years

    CP was defined as no vomiting, no use of rescue therapy and 'no significant nausea' (NSN) during the study periods. NSN is defined as a nausea VAS of <25 mm.

Secondary outcomes

  1. No Nausea (NN)

    Time frame: 2 years

    NN is defined as a nausea VAS of <5 mm.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong LAI, RN

CONTACT

[email protected]

3505 1138

Winnie YEO, MBBS, MD, FRCP

CONTACT

[email protected]

3505 1042

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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