New pill aims to stop chemo sickness in breast cancer patients

NCT ID NCT03386617

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a fixed-dose combination of netupitant and palonosetron (NEPA) to prevent nausea and vomiting in breast cancer patients receiving chemotherapy with adriamycin and cyclophosphamide. The trial includes 55 women in Hong Kong and tracks how well the drug works during the first 24 hours and up to 5 days after chemo. The goal is to improve comfort and reduce side effects during treatment.

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 and palonosetron)
What this could lead to
If it works, this could offer a more effective way to prevent nausea and vomiting during chemotherapy, improving patients' quality of life.
What could go wrong
This is a small, early-phase study with only 55 participants, so results may not apply to everyone. The drug may not work better than existing options.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Started

Feb 2018

Expected to finish

Dec 2028

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 to 74 years

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: * Adult patients ( ≥ 18 and \<75 years), female; a. Chinese patient, female ≥18 and \< 75 years of age. * Patient is diagnosed with early breast cancer. * Patient is scheduled to receive her first course of (neo)- adjuvant chemotherapy for breast cancer follows: * IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2 * ECOG Performance Status of 0-1; * Written informed consent before study entry; * If women of childbearing potential age: reliable contraceptive measures are to be used during all the planned course of the study; * Ability and willingness of the patient to complete the diary and study questionnaires. Exclusion Criteria: * Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study; * Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy; * Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy; * Patients who have taken any of the following agents within 7 calendar days prior to initiation of their chemotherapy regimen: 5-HT3 receptor antagonists, phenothiazines, benzamides, cannabinoids, NK1 receptor antagonists, corticosteroids, or benzodiazepines; * Pregnant or breast-feeding women; * Patient's inability to take oral medication; * Gastrointestinal obstruction or active peptic ulcer; * Psychiatric or CNS disorders interfering with ability to comply with study protocol; * Patients at risk for severe cardiac/cardiovascular disorders * Patients with myocardial infarction within 6 months

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Department of Clinical Oncology, Prince of Wales Hospital

    Hong Kong, Hong Kong

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