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

NCT07254416 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

  • Breast Cancer Patients Treated With T-DXd

Interventions

DRUG

NEPA

On the first day, oral administration of NEPA(netopitan 300mg+ palonosetron 0.50mg)

DRUG

Dexamethasone

On the first day, oral administration of dexamethasone 6mg; From the 2nd to the 4th day, take dexamethasone 3.75mg orally per day.

DRUG

Megestrol Acetate

From the 1st to the 10th day, take 160mg of Megestrol Acetate orally per day.

Sponsors & Collaborators

  • Shaanxi Provincial Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Henan University of Science & Technology

    collaborator UNKNOWN

  • Shanxi Bethune Hospital

    collaborator OTHER

  • Tianjin Cancer Hospital Airport Hospital

    collaborator UNKNOWN

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254416 on ClinicalTrials.gov