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New pill may prevent chemotherapy delays in breast cancer patients

NCT ID NCT05394285

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called hetrombopag in 60 advanced breast cancer patients whose platelets dropped too low from chemotherapy. The goal was to see if the drug could safely raise platelet counts and prevent treatment delays or dose reductions. Patients took the pill daily when platelets were low, and doctors monitored their response.

What this could mean

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

Active substance
hetrombopag olamine tablets
What this could lead to
If it works, this could help advanced breast cancer patients avoid treatment delays or dose reductions due to low platelets, making chemotherapy safer and more effective.
What could go wrong
This is a small, early-phase study with only 60 participants, so results may not apply to all patients. The drug may cause side effects or not work as expected.

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

60 people

The number who actually took part.

Started

Sep 2022

Finished

Jul 2025

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 to 75 years

Sex

Female participants only

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 patients signed the informed consent and voluntarily joined the study; 2. Age 18-75 years old, male or female; 3. Patients with advanced breast cancer diagnosed by histopathology or cytology, who are receiving and continue to receive the same chemotherapy regimen; 4. Can accept the current chemotherapy regimen (must be platinum-containing chemotherapy regimen: lobaplatin, carboplatin, cisplatin, etc.) for at least 2 cycles; 5. The first occurrence of platelets \<50×109/L in the current chemotherapy cycle; 6. The investigator determines that the patient can receive hetrombopag administration; 7. Neutrophil count ≥ 1.0×109/L, hemoglobin ≥ 80g/L before administration of Haitrombopag; 8. Life expectancy at screening ≥ 12 weeks; 9. ECOG: 0-1; 10. The main organ functions are normal, and there are no serious complications. Exclusion Criteria: 1. Women who are pregnant or breastfeeding; 2. Unable to understand the research nature of the research or have not obtained informed consent; 3. The investigator judges other circumstances that are not suitable for inclusion in the study; 4. Thrombocytopenia caused by other causes (chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.); 5. Patients with unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent history (within 1 year of screening) of myocardial infarction; 6. Those with a history of blood disease or tumor bone marrow infiltration; 7. Those who received simultaneous radiotherapy and those who received pelvic radiotherapy in the past; 8. Arterial or venous thrombotic events within the past 6 months; 9. There are currently uncontrollable infections; 10. Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding; 11. Need emergency treatment, such as superior vena cava syndrome, spinal cord compression; 12. The absolute value of neutrophils is less than 1.0×109/L, and the hemoglobin is less than 80g/L, and granulocyte colony-stimulating factor, red blood cells, and EPO infusion therapy in accordance with clinical routine are allowed; 13. Obvious abnormal liver function: patients without liver metastases, ALT/AST\>3ULN (upper limit of normal value), TBIL\>3ULN; patients with liver metastases, ALT/AST≥5ULN, TBIL≥5ULN; 14. Abnormal renal function: serum creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft-Gault formula); 16\. Received thrombopoietin receptor agonist drugs (such as Eltrombopag, Romigrastim), or recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL) within 1 month before screening -11) Treatment; 17. Received platelet transfusion within 3 days before randomization; 18. Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of Hetrombopag ethanolamine tablets.

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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

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Henan Cancer Hospital

    Zhengzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.