Can a pill prevent dangerous platelet drops during breast cancer treatment?
NCT ID NCT07198672
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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- Can a vaccine teach the immune system to fight HER2-Positive tumors?
- Can a tailored Pre-Surgery regimen boost complete remission in HER2+ breast cancer?