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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041004

Enrollment

Registered

2020-07-06

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

granisetron + dexamethasone granisetron + dexamethasone + aprepitant (fosaprepitant)

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Complete response (no emesis, no rescue medication) rate within 120 hours from the start of DS-8201 administration.	—

Countries

Japan

Contacts

Public ContactHirotoshi Iihara

Gifu University Hospital Department of Pharmacy

dai0920@gifu-u.ac.jp058-230-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026