A Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Anti-tumor Treatment in Advanced Breast Cancer

Launched by HENAN CANCER HOSPITAL · May 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called hetrombopag olamine, which is being tested to see how well it works and how safe it is for women with advanced breast cancer who are experiencing low platelet counts due to chemotherapy. Platelets are important for blood clotting, and having low levels can lead to bleeding problems. The trial aims to help doctors understand how hetrombopag can be used to manage this issue in patients undergoing chemotherapy.

To join the study, participants need to be women aged 18 to 75 who have been diagnosed with advanced breast cancer and are currently receiving a specific type of chemotherapy that includes platinum-based drugs. They must have experienced a drop in their platelet count to below 50,000 per microliter during their current chemotherapy cycle. Participants will be closely monitored throughout the trial, and their health will be assessed to ensure they can safely take hetrombopag. This study is currently recruiting, and it offers an opportunity for eligible patients to potentially improve their treatment experience.

Gender

FEMALE

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.