Breast Cancer
Conditions
Brief 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.
Detailed description
Cancer therapy-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 cancer therapy-induced thrombocytopenia (CTIT). 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 CTIT patients is ongoing. 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 therapy-induced platelets.
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.
Sponsors
Henan Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The response rates to platelet-raising therapy in prevention stage | 30day±3day after the last administration of Hetrombopag Olamine Tablets | The response rate defined as the proportion of pts not requiring platelet transfusion or adjustment (dose reduction 20%, treatment delays for ≥5 days, or treatment discontinuation) due to thrombocytopenia, and not developing severe thrombocytopenia (PLT \< 25×10⁹/L, or PLT \<50×10⁹/L for \>7 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The response rate to platelet-raising therapy in treatment stage; | 30day±3day after the last administration of Hetrombopag Olamine Tablets or rh TPO | The response rate defined as the treatment of pts not requiring platelet transfusion or adjustment (dose reduction 20%, treatment delays for ≥5 days, or treatment discontinuation) due to thrombocytopenia, and not developing severe thrombocytopenia (PLT \< 25×10⁹/L, or PLT \<50×10⁹/L for \>7 days). |
| The lowest platelet value after anti-tumor treatment; | 30day±3day after the last administration of Hetrombopag Olamine Tablets | The lowest platelet value after anti-tumor treatment; |
| The incidence of platelets <50×109/L and <25×109/L; | 30day±3day after the last administration of Hetrombopag Olamine Tablets | The incidence of platelets \<50×109/L and \<25×109/L; |
| The duration of platelets <50×109/L and <25×109/L; | 30day±3day after the last administration of Hetrombopag Olamine Tablets | The duration of platelets \<50×109/L and \<25×109/L; |
| The time for platelets to recover to more than 100×109/L; | 30day±3day after the last administration of Hetrombopag Olamine Tablets | The time for platelets to recover to more than 100×109/L; |
| latelet recovery to the highest value after anti-tumor treatment; | 30day±3day after the last administration of Hetrombopag Olamine Tablets | latelet recovery to the highest value after anti-tumor treatment; |
| the incidence of adverse events; | 30day±3day after the last administration of Hetrombopag Olamine Tablets | the incidence of adverse events; |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORmin yan
Henan Cancer Hospital
Outcome results
None listed