Clinical trial NCT05394285: A Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer
Official title: A Single-center, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2022-05-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Chemotherapy-induced thrombocytopenia increases the risk of hemorrhagic complications, the need for platelet transfusions, and limits the dose of cytotoxic drugs in the treatment of certain malignancies. Thrombopoietin receptor agonist (TPO-RA) has a therapeutic effect on chemotherapy-induced thrombocytopenia (CIT). As an innovative TPO-RA drug, hetrombopag has a more optimized molecular structure and reduced liver and kidney toxicity. A registrational Phase III clinical study in CIT patients is ongoing. This study now plans to explore the efficacy and safety of hetrombopag in chemotherapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

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.

Primary outcomes:
measure: Comparison of response rates to platelet-raising therapy in two chemotherapy cycles
timeFrame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
Secondary outcomes:
measure: The lowest platelet value after chemotherapy;
timeFrame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
measure: The incidence of platelets <50×109/L and <25×109/L;
timeFrame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
measure: The duration of platelets <50×109/L and <25×109/L;
timeFrame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
measure: The time for platelets to recover to more than 100×109/L;
timeFrame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
measure: latelet recovery to the highest value after chemotherapy;
timeFrame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
measure: the incidence of adverse events;
timeFrame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Henan Cancer Hospital
name: min yan
role: PRINCIPAL_INVESTIGATOR
References: