Hetrombopag for treating low platelet counts in advanced breast cancer patients undergoing chemotherapy

A Single-center, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer

This study is testing if hetrombopag can help women with advanced breast cancer who have low platelet counts from chemotherapy feel better and continue their treatment safely.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Zhengzhou, Henan and 1 other locations)
• Trial ID: NCT05394285 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of hetrombopag, a thrombopoietin receptor agonist, in patients with advanced breast cancer who are experiencing chemotherapy-induced thrombocytopenia. The study aims to determine how well hetrombopag can manage low platelet counts, which can lead to complications and limit chemotherapy dosing. Participants will be receiving a platinum-containing chemotherapy regimen and will be monitored for their response to hetrombopag treatment. The goal is to optimize the use of this medication in clinical settings for patients facing similar challenges.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced breast cancer undergoing a platinum-containing chemotherapy regimen and experiencing low platelet counts.

Not a fit: Patients who are pregnant, breastfeeding, or unable to understand the nature of the study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of bleeding complications and improve the ability to continue effective chemotherapy for patients with advanced breast cancer.

How similar studies have performed: Other studies have shown promising results with thrombopoietin receptor agonists in managing chemotherapy-induced thrombocytopenia, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Zhengzhou, Henan and 1 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)

Study contacts

• Principal investigator: min yan — Henan Cancer Hospital
• Study coordinator: min yan

Conditions Breast Cancer