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New combo aims to stop nausea in breast cancer patients

NCT ID NCT07254416

Symptom relief Sponsor: Tianjin Medical University Cancer Institute and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of two anti-nausea drugs (NEPA plus megestrol acetate) works better than the standard regimen (NEPA plus dexamethasone) for preventing nausea and vomiting in breast cancer patients receiving T-DXd therapy. 120 participants will be randomly assigned to one of the two groups. The goal is to improve quality of life and help patients stay on their cancer treatment without dose reductions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NEPA (netupitant/palonosetron), megestrol acetate, dexamethasone
What this could lead to
If successful, this could offer a better way to prevent nausea and vomiting in breast cancer patients on T-DXd, improving quality of life and reducing treatment interruptions.
What could go wrong
This is a small, early-stage trial (Phase 4) with only 120 participants. The new combination may not be more effective than the standard regimen, and side effects from the drugs themselves are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer patients treated with T-DXD

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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