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
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000041004
- Lead Sponsor
- Gifu University
- Brief Summary
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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response (no emesis, no rescue medication) rate within 120 hours from the start of DS-8201 administration.
- Secondary Outcome Measures
Name Time Method