UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058996 |
|---|---|
| Receipt number | R000067470 |
| Scientific Title | A Multicenter Prospective Exploratory Interventional Study on the Efficacy and Safety of Single-Day Administration of Palonosetron, Fosnetupitant, and Dexamethasone for Sacituzumab Govitecan-Induced Nausea and Vomiting in Patients with Breast Cancer, and the Addition of Olanzapine in Antiemetic-Refractory Cases |
| Date of disclosure of the study information | 2025/09/04 |
| Last modified on | 2025/09/04 18:08:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multicenter Prospective Exploratory Interventional Study on the Efficacy and Safety of Single-Day Administration of Palonosetron, Fosnetupitant, and Dexamethasone for Sacituzumab Govitecan-Induced Nausea and Vomiting in Patients with Breast Cancer, and the Addition of Olanzapine in Antiemetic-Refractory Cases
Acronym
A Multicenter Prospective Exploratory Interventional Study on the Efficacy and Safety of Single-Day Administration of Palonosetron, Fosnetupitant, and Dexamethasone for Sacituzumab Govitecan-Induced Nausea and Vomiting in Patients with Breast Cancer, and the Addition of Olanzapine in Antiemetic-Refractory Cases
Scientific Title
A Multicenter Prospective Exploratory Interventional Study on the Efficacy and Safety of Single-Day Administration of Palonosetron, Fosnetupitant, and Dexamethasone for Sacituzumab Govitecan-Induced Nausea and Vomiting in Patients with Breast Cancer, and the Addition of Olanzapine in Antiemetic-Refractory Cases
Scientific Title:Acronym
PerSeUS-BC07
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the complete response rate in patients with breast cancer receiving sacituzumab govitecan (SG) when administered a single-day combination of palonosetron, fosnetupitant, and dexamethasone as antiemetic prophylaxis. Furthermore, in cases where total control of nausea and vomiting is not achieved, the efficacy and safety of additional olanzapine administration will be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response (no vomiting and no use of rescue medication) rate within 5 days (120 hours) from the start of the initial SG administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
palonosetron + fosnetupitant + dexamethasone
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Female patients with breast cancer.
Patients scheduled to receive SG administration for the first time.
Patients scheduled to start SG at the standard dose.
Age >= 20 years at the time of enrollment.
No use of the following concomitant medications within 48 hours prior to enrollment:
Selective serotonin reuptake inhibitors (SSRI)
Serotonin-norepinephrine reuptake inhibitors (SNRI)
Serotonin-dopamine antagonists (SDA)
Multi-acting receptor targeted antipsychotics (MARTA)
NK1 receptor antagonists
5-HT3 receptor antagonists
Corticosteroids (except topical use)
Dopamine antagonists
Phenothiazine-type tranquilizers
Benzodiazepines (including thienodiazepines)
Other centrally acting drugs
Laboratory data within one month prior to enrollment meeting all of the following criteria:
Total bilirubin <= 2.0 mg/dL
AST <= 100 U/L
ALT <= 100 U/L
Written informed consent obtained from the patient.
Key exclusion criteria
Patients with a history of allergy to the study drugs or related compounds.
Patients with diabetes mellitus receiving treatment with insulin or any oral hypoglycemic agents, as well as those with HbA1c (NGSP) >= 6.5% or HbA1c (JDS) >= 6.1% at enrollment. Patients for whom additional blood glucose monitoring (outside the scheduled tests) may lead to dose reduction or discontinuation of dexamethasone will also be excluded.
Patients presenting with nausea or vomiting requiring antiemetic treatment at the time of enrollment.
Patients who initiated opioid therapy (strong opioids) within 48 hours prior to enrollment.
Patients with a history of any of the following within 6 months prior to enrollment: unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, or active gastric/duodenal ulcer.
Patients with convulsive disorders requiring anticonvulsant therapy.
Patients with ascites requiring therapeutic paracentesis.
Patients with gastrointestinal obstruction, such as pyloric stenosis or ileus.
Pregnant or lactating women, women who may be pregnant, or patients unwilling to use adequate contraception.
Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult.
Any other patients deemed inappropriate for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Futamura |
Organization
Gifu University Hospital
Division name
Department of Breast Surgery
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6000
futamura.manabu.m3@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Tomida |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6000
Homepage URL
tomida.atsuko.e4@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee of the Gifu Universit y Graduate School of Medicine
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@gifu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067470
