RecruitingPhase 2NCT07455955

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.

Sponsor

Chinese University of Hong Kong

Enrollment

200 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether analyzing a breast cancer patient's genetic profile (pharmacogenetics) before chemotherapy can help doctors choose the best anti-nausea medication regimen, potentially with or without olanzapine. Nausea and vomiting are serious side effects of AC and FEC chemotherapy regimens commonly used for early breast cancer. You may be eligible if you are a Chinese woman aged 18 to under 75 with early breast cancer, scheduled to begin your first course of AC or FEC chemotherapy, with no prior history of moderately or highly emetogenic chemotherapy. Participation involves a genetic test at the start, taking assigned anti-nausea medications with each chemotherapy cycle, and completing quality-of-life questionnaires throughout treatment. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard antiemetic regimen or Olanzapine antiemetic regimen

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

DRUGStandard antiemetic regimen

* 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

Locations(1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

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NCT07455955

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