Breast CancerPhase 3NCT03079219
Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients
A Phase 3 study testing Experimental drug: Aprepitant, Experimental drug: Ondansetron and Experimental drug: Dexamethasone in people with Breast Cancer, run by CCTU at 1 site in Hong Kong.
Trial summary
The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the proportion of patients with Complete Response in the 120 hours following AC chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Experimental drug: Aprepitant, Experimental drug: Ondansetron and Experimental drug: Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Mar 2017to 1 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 emetogenecity.
- Patient is scheduled to receive her first course of adjuvant chemotherapy for breast cancer follows:
- IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2
- Patient has a predicted life expectancy of >=4 months.
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- Patient has ECOG 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
Who cannot join
- 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.
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- 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;
- Patient is taking systemic corticosteroid therapy at any dose; however, topical and inhaled corticosteroids are permitted.
- Patient has taken a non-registered investigational drug within the 28 days of the Prestudy Visit.
- Use, in the 28 days prior to Treatment Day 1, of barbiturates, rifampicin or rifabutin, phenytoin or carbamazepine
- Use, in the 7 days prior to Treatment Day 1, of terfenadine, cisapride, astemizole, clarithromycin (azithromycin, erythromycin and roxithromycin are permitted), ketoconazole or itraconazole (fluconazole is permitted), amifostine pimozide 5-HT3 antagonists (ondansetron, granisetron, dolasetron, or tropisetron) phenothiazines (e.g., prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine) butyrophenones (e.g., haloperidol or droperidol) benzamides (e.g., metoclopramide or alizapride) domperidone cannabinoids NK1 receptor antagonists
- Use, in the 48 hours prior to Treatment Day 1, of benzodiazepines or opiates, except for single daily doses of lorazepam.
- Use of the following drugs: carbamazepine Fluvoxamine ciprofloxacin dopamine agonists. antiparkinsonian medicinal products medicinal products known to increase QTc interval t. Abnormal laboratory values
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: A Randomized Study to Determine the Efficacy and Tolerability of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients
The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the proportion of patients with Complete Response in the 120 hours following AC chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Experimental drug: Aprepitant, Experimental drug: Ondansetron, Experimental drug: Dexamethasone, Experimental drug: Olanzapine, Standard: Aprepitant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental drug: AprepitantDrug
Day 1: 125mg QD; Day 2 to Day 3: 80mg QD
Experimental drug: OndansetronDrug
Day 1: 8mg BD, First dose 8mg, Second dose 8mg, 8 hours after first dose
Experimental drug: DexamethasoneDrug
Day 1: 12mg QD
Experimental drug: OlanzapineDrug
Day 1 to Day 5: 10mg QD
Standard: AprepitantDrug
Day 1: 125mg QD, Day 2 to Day3: 80mg QD
Standard: OndansetronDrug
Day 1: 8mg BD, First dose 8mg, second dose 8mg, 8 hours after first dose
Standard: DexamethasoneDrug
Day 1: 12mg QD ; Day 2 to Day 3: 4mg BD
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Aprepitant, Ondansetron, Dexamethasone and Olanzapine Receives: Drug: Experimental drug: Aprepitant; Drug: Experimental drug: Ondansetron; Drug: Experimental drug: Dexamethasone; Drug: Experimental drug: Olanzapine |
| Standard | Other | Aprepitant, Ondansetron, Dexamethasone Receives: Drug: Standard: Aprepitant; Drug: Standard: Ondansetron; Drug: Standard: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.
Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.
Measured: 120 hours
Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.
Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.
Measured: 120 hours
Secondary outcomes (2)
Number of episodes of nausea in the first 120 hours during 4 cycles of chemotherapy.
Number of episodes of nausea in the first 120 hours during 4 cycles of chemotherapy.
Measured: 120 hours
Number of episodes of vomiting in the first 120 hours during 4 cycles of chemotherapy.
Number of episodes of vomiting in the first 120 hours during 4 cycles of chemotherapy.
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start23 Mar 2017
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CCTU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Winnie Yeo, MD, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079219
- Sponsor's protocol ID
- SYM010
- Status last verified
- Jul 2021
- First submitted
- 8 Feb 2017
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Determine the Efficacy and Tolerability of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03079219
- Acronym / sponsor ID
- SYM010
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CCTUUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the proportion of patients with Complete Response in the 120 hours following AC chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Experimental drug: Aprepitant, Drug: Experimental drug: Ondansetron, Drug: Experimental drug: Dexamethasone, Drug: Experimental drug: OlanzapineAprepitant, Ondansetron, Dexamethasone and Olanzapine |
| Standard | Other | Drug: Standard: Aprepitant, Drug: Standard: Ondansetron, Drug: Standard: DexamethasoneAprepitant, Ondansetron, Dexamethasone |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 emetogenecity.
- Patient is scheduled to receive her first course of adjuvant chemotherapy for breast cancer follows:
- IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental drug: AprepitantDay 1: 125mg QD; Day 2 to Day 3: 80mg QD | Drug | Experimental |
| Experimental drug: OndansetronDay 1: 8mg BD, First dose 8mg, Second dose 8mg, 8 hours after first dose | Drug | Experimental |
| Experimental drug: DexamethasoneDay 1: 12mg QD | Drug | Experimental |
| Experimental drug: OlanzapineDay 1 to Day 5: 10mg QD | Drug | Experimental |
| Standard: AprepitantDay 1: 125mg QD, Day 2 to Day3: 80mg QD | Drug | Standard |
| Standard: OndansetronDay 1: 8mg BD, First dose 8mg, second dose 8mg, 8 hours after first dose | Drug | Standard |
| Standard: DexamethasoneDay 1: 12mg QD ; Day 2 to Day 3: 4mg BD | Drug | Standard |
Primary outcome
Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.
Time frame: 120 hours
Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.
Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.
Time frame: 120 hours
Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.
2 secondary outcomes
Number of episodes of nausea in the first 120 hours during 4 cycles of chemotherapy.
Time frame: 120 hours
Number of episodes of vomiting in the first 120 hours during 4 cycles of chemotherapy.
Time frame: 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winnie Yeo, MD, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental drug: Aprepitant, Experimental drug: Ondansetron and Experimental drug: Dexamethasone in people with Breast Cancer, run by CCTU at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy. (time frame: 120 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.