A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
Status:
NOT_YET_RECRUITING
Trial end date:
2027-06-30
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborators:
Shaanxi Provincial Cancer Hospital Shanxi Bethune Hospital The First Affiliated Hospital of Henan University of Science & Technology Tianjin Cancer Hospital Airport Hospital