UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041004 |
|---|---|
| Receipt number | R000046804 |
| Scientific Title | To establish of optimal antiemetic therapy for trastuzumab deruxtecan therapy-induced nausea and vomiting in patients with breast cancer:an open-label, randomized pilot study |
| Date of disclosure of the study information | 2020/07/06 |
| Last modified on | 2024/01/07 17:45:00 |
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Basic information
Public title
To establish of optimal antiemetic therapy for trastuzumab deruxtecan therapy-induced nausea and vomiting in patients with breast cancer:an open-label, randomized pilot study
Acronym
To establish of optimal antiemetic therapy for trastuzumab deruxtecan therapy-induced nausea and vomiting in patients with breast cancer:an open-label, randomized pilot study
Scientific Title
To establish of optimal antiemetic therapy for trastuzumab deruxtecan therapy-induced nausea and vomiting in patients with breast cancer:an open-label, randomized pilot study
Scientific Title:Acronym
To establish of optimal antiemetic therapy for trastuzumab deruxtecan therapy-induced nausea and vomiting in patients with breast cancer:an open-label, randomized pilot study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the complete responce using granisetron, dexamethasone or granisetron + dexamethasone + aprepitant(fosaprepitant) as an antiemetic treatment in patients with breast cancer who will be treated with trastuzumab deruxtecan(DS-8201).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response (no emesis, no rescue medication) rate within 120 hours from the start of DS-8201 administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
granisetron + dexamethasone
Interventions/Control_2
granisetron + dexamethasone + aprepitant (fosaprepitant)
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
1. Female patients with breast cancer
2. Patients with no history of administration of DS-8201
2. Patients aged >= 20 years old
4. Patients who do not take a medicine regularly, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc.
5. Patients who meet the following standard values in general clinical tests:
AST and ALT <=100U/L
Total bilirubin <=2.0mg/dL
6. Written informed consent
Key exclusion criteria
1. History of hypersensitivity or allergy for study drugs or similar compounds.
2. Patients who need antiemetics at the enrollment.
3. Patients who start taking opioids within 48 hours prior to enrollment.
4. Patient with unstable angina, ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenal ulcer within 6 months prior to enrollment.
5. Patients who have convulsive disorders requiring anticonvulsants therapy
6. Patients with ascites effusion requiring paracentesis
7. Patients who have gastrointestinal obstruction
8. Pregnant, breastfeeding or expecting women or who do not wish to use contraception
9. Patients who have psychosis or psychiatric symptoms that interferes with daily life
10. Patients who are judged to be inappropriate for the study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Futamura |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
500-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6000
mfutamur@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Iihara |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
500-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6000
Homepage URL
dai0920@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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 University Graduate School of Medicine
Address
1-1 Yanagido, Gifu, 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
| 2020 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jcancer.org/v14p2644.htm
Number of participants that the trial has enrolled
40
Results
The overall CR rates were 36.8% and 70.0% in the GD and GDA arms, respectively (odds ratio 0.1334; 95% confidence interval [CI]: 0.0232-0.7672; P = 0.0190), with a difference of 33.2%.
Results date posted
| 2024 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 28 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046804
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