RecruitingPhase 2NCT05394285

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

A Multicenter, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Anti-tumor Treatment in Advanced Breast Cancer

Sponsor

Henan Cancer Hospital

Enrollment

60 participants

Start Date

Aug 19, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This study now plans to explore the efficacy and safety of hetrombopag in cancer therapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

The patients signed the informed consent and voluntarily joined the study;
Age 18-75 years old, male or female;
Patients with advanced breast cancer diagnosed by histopathology or cytology, who are receiving and continue to receive the same chemotherapy regimen;
Can accept the current chemotherapy regimen (must be platinum-containing chemotherapy regimen: lobaplatin, carboplatin, cisplatin, etc.) for at least 2 cycles;
The first occurrence of platelets \<50×109/L in the current chemotherapy cycle;
The investigator determines that the patient can receive hetrombopag administration;
Neutrophil count ≥ 1.0×109/L, hemoglobin ≥ 80g/L before administration of Haitrombopag;
Life expectancy at screening ≥ 12 weeks;
ECOG: 0-1;
The main organ functions are normal, and there are no serious complications.

Exclusion Criteria15

Women who are pregnant or breastfeeding;
Unable to understand the research nature of the research or have not obtained informed consent;
The investigator judges other circumstances that are not suitable for inclusion in the study;
Thrombocytopenia caused by other causes (chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
Patients with unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent history (within 1 year of screening) of myocardial infarction;
Those with a history of blood disease or tumor bone marrow infiltration;
Those who received simultaneous radiotherapy and those who received pelvic radiotherapy in the past;
Arterial or venous thrombotic events within the past 6 months;
There are currently uncontrollable infections;
Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding;
Need emergency treatment, such as superior vena cava syndrome, spinal cord compression;
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;
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;
Abnormal renal function: serum creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft-Gault formula);
\. 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.

Interventions

DRUGHetrombopag

The first anti-tumor treatment cycle (multicenter, open label, randomized controlled): When platelets were \<50\*109/L, oral hetrombopag 7.5 mg/day was started. When the platelet count is \>100\*109/L, the administration is suspended. 2nd anti-tumor treatment cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after anti-tumor treatment for 14 days.