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NCT Number: NCT07254416

A Study on 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.

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Key information

Conditions

Breast Cancer Patients Treated With T-DXd

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • 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;
  • The patient is deemed unsuitable for glucocorticoid or progesterone use;
  • The patient has a history of hypersensitivity to netupitant, palonosetron, or any excipient in the capsule formulation;
  • The patient has significant gastrointestinal conditions affecting oral drug absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction;
  • The patient has a severe psychiatric disorder or difficulties understanding the study procedures, completing questionnaires, or communicating effectively in Chinese;
  • The investigator identifies any other condition that may compromise the conduct of the clinical study or the interpretation of its results.

Treatment and study plan

NEPA

Drug

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

Dexamethasone

Drug

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

Megestrol acetate

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. The time and duration of the first significant nausea and vomiting.

    Time frame: From the administration of T-Dxd to 21 days

  5. The proportion of patients undergoing salvage treatment.

    Time frame: From the administration of T-Dxd to 21 days

  6. The incidence of ADC reduction due to adverse reactions

    Time frame: From the administration of T-Dxd to 21 days

  7. Evaluation of the EORTC QLQ-C30 (version 3) Quality of Life Questionnaire.

    Time frame: From the administration of T-Dxd to 21 days

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Shaanxi Provincial Cancer Hospital
  • Shanxi Bethune Hospital
  • The First Affiliated Hospital of Henan University of Science and Technology
  • Tianjin Cancer Hospital Airport Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.