NCT07455955

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
24mo left

Started Mar 2026

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026Jul 2028

First Submitted

Initial submission to the registry

March 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 3, 2026

Last Update Submit

March 31, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Complete Protection (CP)

    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.

    2 years

Secondary Outcomes (1)

  • No Nausea (NN)

    2 years

Study Arms (2)

PG arm

EXPERIMENTAL

In PG arms, there are 4 PG subgroups: * Subgroup A: Standard antiemetic regimen will be given. * Subgroup B: Standard antiemetic regimen will be given. * Subgroup C: Olanzapine antiemetic regimen will be given. * Subgroup D: Olanzapine antiemetic regimen will be given.

Drug: Standard antiemetic regimen or Olanzapine antiemetic regimen

Non-PG arm

EXPERIMENTAL

Standard antiemetic regimen will be given.

Drug: Standard antiemetic regimen

Interventions

Standard antiemetic regimen or Olanzapine antiemetic regimenDRUG

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

PG arm
Standard antiemetic regimenDRUG

* 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

Non-PG arm

Eligibility Criteria

Age18 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Winnie YEO, MBBS, MD, FRCP

CONTACT

3505 1042winnie@clo.cuhk.edu.hk

Dong LAI, RN

CONTACT

3505 1138dong@clo.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Clinical Oncology

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

June 3, 2027

Study Completion (Estimated)

July 3, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)