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

NCT ID: NCT07254416

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NEPA+ Megestrol Acetate

Group Type: EXPERIMENTAL

NEPA

Intervention Type: DRUG

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

Megestrol Acetate

Intervention Type: DRUG

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

NEPA+ Dexamethasone

Group Type: ACTIVE_COMPARATOR

NEPA

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Interventions

NEPA

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

Intervention Type: 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.

Intervention Type: DRUG

Megestrol Acetate

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaanxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan University of Science & Technology

UNKNOWN

Sponsor Role: collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role: collaborator

Tianjin Cancer Hospital Airport Hospital

UNKNOWN

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AKZ-ADC-01

Identifier Type: -

Identifier Source: org_study_id