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

November 19, 2025 updated by: Tianjin Medical University Cancer Institute and Hospital

To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient is at least 18 years of age;
  2. The patient has a histologically or cytologically confirmed diagnosis of breast cancer;
  3. The patient is receiving full-dose trastuzumab deruxtecan (T-DXd) monoclonal antibody therapy for the first time;
  4. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or lower;
  5. The patient voluntarily agrees to comply fully with the study protocol requirements and has provided written informed consent.

Exclusion Criteria:

  1. The patient is currently taking medications that may interfere with the assessment of nausea or vomiting, including but not limited to other 5-HT3 receptor antagonists, NK1 receptor antagonists, psychotropic agents, or opioid analgesics;
  2. The investigator determines that the patient's nausea or vomiting is highly likely attributable to anti-tumor treatments not involving antibody-drug conjugate (ADC) therapy;
  3. The patient is deemed unsuitable for glucocorticoid or progesterone use;
  4. The patient has a history of hypersensitivity to netupitant, palonosetron, or any excipient in the capsule formulation;
  5. The patient has significant gastrointestinal conditions affecting oral drug absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction;
  6. The patient has a severe psychiatric disorder or difficulties understanding the study procedures, completing questionnaires, or communicating effectively in Chinese;
  7. The investigator identifies any other condition that may compromise the conduct of the clinical study or the interpretation of its results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEPA+ Megestrol Acetate
Drug: NEPA
On the first day, oral administration of NEPA(netopitan 300mg+ palonosetron 0.50mg)
Drug: Megestrol Acetate
From the 1st to the 10th day, take 160mg of Megestrol Acetate orally per day.
Active Comparator: NEPA+ Dexamethasone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment
Time Frame: 0-120 hours (0-5 days)
0-120 hours (0-5 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment
Time Frame: 0-120 hours (0-5 days)
0-120 hours (0-5 days)
The CR rates of 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment.
Time Frame: 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours
0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours
The CC rates of 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment.
Time Frame: 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours
0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours
The time and duration of the first significant nausea and vomiting.
Time Frame: From the administration of T-Dxd to 21 days
From the administration of T-Dxd to 21 days
The proportion of patients undergoing salvage treatment.
Time Frame: From the administration of T-Dxd to 21 days
From the administration of T-Dxd to 21 days
The incidence of ADC reduction due to adverse reactions
Time Frame: From the administration of T-Dxd to 21 days
From the administration of T-Dxd to 21 days
Evaluation of the EORTC QLQ-C30 (version 3) Quality of Life Questionnaire.
Time Frame: From the administration of T-Dxd to 21 days
From the administration of T-Dxd to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKZ-ADC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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