drugset
drugset / Trial / NCT07254416

A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients

NCT07254416 ↗

Phase 4 Not yet recruiting 120 enrolled Tianjin Medical University Cancer Institute and Hospital Shaanxi Provincial Cancer Hospital · collabShanxi Bethune Hospital · collabThe First Affiliated Hospital of Henan University of Science and Technology · collabTianjin Cancer Hospital Airport Hospital · collab
RandomizedParallel-groupOpen-labelPrevention

Summary

This study was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. The intervention was administered over two treatment cycles. During this period, the onset time, frequency, and severity of nausea and vomiting were recorded and subjected to statistical analysis. The primary objective of this study was to evaluate the efficacy and safety of netupitant/palonosetron capsules (NEPA) combined with megestrol acetate compared to the standard triple antiemetic regimen (NEPA plus dexamethasone) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients undergoing T-DXd-containing regimens. The findings aim to generate clinical evidence to support optimal antiemetic management, minimize the risk of dose reduction or treatment discontinuation due to gastrointestinal adverse events, and ultimately improve patient quality of life.

Timeline

Start
2025-12-15
Primary completion
2026-12-31
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 3.75 mg Oral
Subject Megestrol Acetate Other / unclassified 160 mg Oral
Background Netupitant Small molecule 300 mg Oral
Background Palonosetron Other / unclassified 0.5 mg Oral

Indications

No indication recorded.