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

Tianjin Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Breast Cancer Patients Treated With T-DXd

Treatments: Drug: NEPA; Drug: Megestrol Acetate; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07254416

AKZ-ADC-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

NEPA+ Megestrol Acetate

Experimental group

Treatment:

Drug: Megestrol Acetate

Drug: NEPA

NEPA+ Dexamethasone

Active Comparator group

Treatment:

Drug: Dexamethasone

Drug: NEPA