breast cancer patients with chemotherapy-induced thrombocytopenia
Conditions
Interventions
Test group:Herombopag Olamine Tabletsin
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Voluntarily participate in the experiment and sign the informed consent; 2. Aged >= 18 years, no gender limitation; 3. Diagnosis of breast cancer by histopathological or cytological examination; 4. The current chemotherapy regimen the patient is receiving requires the use of one or more of the following chemotherapy drugs: (1) Phytochemicals, including taxanes, albumin-bound paclitaxel, etc.; (2) Antimetabolites, including gemcitabine; (3) Platinum, including carboplatin, nedaplatin, cisplatin, loplatin, etc.; (4) Anthracycline, including doxorubicin, daunorubicin, epirubicin, etc.; (5) Alkylation agents, including cyclophosphamide, isocyclophosphamide, etc.; (6)Immunotherapy, PD-1 inhibitors, PD-L1 inhibitors, etc; (7)Targeted therapy,Trastuzumab,Pertuzumab,TDM-1, etc; (8)Antiangiogenic drugs,Apatinib, etc; (9)Radiotherapy, etc. 5. Platelet = 12 weeks and can receive at least one cycle of current chemotherapy regimen; 8. Subjects of reproductive age agree to use reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive membrane, contraceptive ointment, contraceptive plug, abstinence, and placement of intrauterine device) throughout the study period; Women who had undergone hysterectomy, bilateral salpingectomy, bilateral salpingligation, or more than 1 year after menopause and men who had bilateral vasectomy or ligation were excluded; 9. The inestigators determined that the patient could be treated with thrombogenic agents; 10. Voluntarily participated in the study and signed the informed consent with good compliance.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions cannot be enrolled in this study: 1. Screening or baseline platelet value 1.5uln (upper limit of normal), > 3ULN for patients with known Gilbert syndrome; ALT/AST > 3ULN in patients without liver metastasis; Patients with liver metastasis, ALT/AST >= 5ULN; 12. Abnormal renal function: serum creatinine >= 1.5ULN or eGFR <= 60 mL /min (Cockcroft-Gault formula); 13. Received platelet transfusion within the first 3 days of randomization; 14. Patients with known or expected allergy or intolerance to the active ingredients or excipients of Hygropaethanolamine tablets; 15. HIV infected persons; 16. Pregnant or lactating women; 17. Participated in any other clinical study of an investigational drug or device within 28 days prior to screening; 18. Inability to swallow, inflammatory bowel disease, or uncontrollable nausea, vomiting, diarrhea, or other gastrointestinal disorders that significantly affect drug administration and absorption; 19. Participation in the study is considered by the investigator to pose a significant risk to the health or safety of the subjects or other conditions that may affect the efficacy assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who were effective after treatment with Herombopag Olamine Tabletsin was defined as having platelet values restored to >= 75x10^9/L with an increase of at least 30x10^9/L from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients whose platelet values recovered to >= 100x10^9/L after Herombopag Olamine Tabletsin therapy;Platelet infusion rate after Herombopag Olamine Tabletsin treatment;The incidence of reduced cycle therapy intensity due to thrombocytopenia (reduced or delayed chemotherapy); | — |
Countries
China
Contacts
Public ContactHanfang Jiang
Beijing Cancer Hospital
Outcome results
None listed