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Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile | Clinical Trials | Clareo Health

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Personalized Antiemetic Regimen According to Patients' Pharmacogenetic 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.

NCT07455955•Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 74 years

Sex

FEMALE

Healthy Volunteers

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
+4 more criteria

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Key Dates

Start Date

June 3, 2026

Primary Completion Date

June 3, 2027

Completion Date

July 3, 2028

Last Updated

March 11, 2026

Enrollment

200

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Standard antiemetic regimen or Olanzapine antiemetic regimen

DRUG

Standard antiemetic regimen

DRUG

Contacts

Winnie YEO, MBBS, MD, FRCP

CONTACT

3505 1042 winnie@clo.cuhk.edu.hk

Dong LAI, RN

CONTACT

3505 1138 dong@clo.cuhk.edu.hk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile

Inclusion Criteria

Exclusion Criteria

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