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Can a pill prevent dangerous platelet drops during breast cancer treatment?

NCT ID NCT07198672

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether herombopag tablets can prevent low platelet counts in 45 women with HER2-positive breast cancer who are receiving T-DM1 therapy. T-DM1 is effective but often causes low platelets, especially in Asian patients, which can force treatment delays or dose reductions. Participants will take herombopag at the start of each T-DM1 cycle to see if it keeps platelet levels safe.

What this could mean

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

Active substance
herombopag olamine tablets
What this could lead to
If it works, this could offer a way to prevent dangerous low platelet counts in HER2+ breast cancer patients on T-DM1, helping them complete their cancer therapy without delays or dose cuts.
What could go wrong
This is a small, early exploratory study with no control group, so results may not be definitive. The drug may not prevent low platelets effectively or could cause side effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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. Female, age ≥18 years; 2. Histopathologically or cytologically confirmed diagnosis of breast cancer; 3. Tumor tissue confirmed as HER2-positive, defined as immunohistochemistry (IHC) showing +++, or IHC++ with fluorescence in situ hybridization (FISH) demonstrating HER2-positive status; 4. Planned to receive T-DM1 regimen based on clinical judgment; 5. ECOG PS score: 0-2; 6. Expected survival greater than 12 weeks; 7. Adequate organ and bone marrow function. Exclusion Criteria: 1. A confirmed history of severe allergic reactions to the active ingredients or excipients of the therapeutic drug; 2. Presence of other underlying diseases or comorbidities causing thrombocytopenia, such as aplastic anemia, immune thrombocytopenia, myelodysplastic syndrome, etc.; 3. Individuals with hereditary bleeding disorders, coagulation dysfunction, high bleeding risk, or a history of thrombotic events (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months prior to initial medication use; 4. Individuals with uncontrolled hypertension and a history of hypertensive crisis or hypertensive encephalopathy; 5. Pregnant or lactating women; 6. Presence of multiple factors affecting oral drug absorption, such as dysphagia, nausea/vomiting, chronic diarrhea, or intestinal obstruction; 7. History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction; 8. Currently participating in interventional clinical research treatment, or having received other investigational drugs or devices within 4 weeks prior to first dosing (individuals who failed screening for other clinical trials may be included in this study); 9. Any other factors deemed by the investigator to increase study risk, affect patient compliance with the protocol, or impact the patient's ability to complete the trial, such as physiological or psychological conditions that make participation in this study inappropriate;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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