Thrombocytopenia in Patients Treated with T-DM1
Conditions
Interventions
Experimental group:Begin administration of Herombopag Olamine Tablets 7.5 mg once daily (qd) 24 hours after T-DM1 infusion. Continue for 14 consecutive days to maintain platelet count >=100 × 10^9/L.
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, no gender restrictions; 2. Pathologically or cytologically confirmed breast cancer, having received neoadjuvant anti-HER2 therapy followed by T-DM1 adjuvant therapy; 3. Grade 2 or higher tumor-treatment-related thrombocytopenia during the previous T-DM1 treatment cycle, with platelet count restored to >=100×10?/L and =12 weeks, with capacity to undergo at least 2 cycles of the current treatment regimen; 7. Expected good compliance, able to follow protocol requirements for monitoring efficacy and adverse reactions; 8. Voluntary participation in this clinical trial, understanding of study procedures, and ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other malignancies within the past 3 years; 2. Patients with psychiatric or neurological disorders who are unable to cooperate; 3. Patients scheduled for or who have previously undergone organ or bone marrow transplantation; 4. Other hematopoietic system disorders excluding chemotherapy-induced thrombocytopenia (CIT), such as but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndromes; 5. History of any arterial or venous thrombosis within 6 months prior to screening; 6. Severe bleeding manifestations within 2 weeks prior to screening, such as gastrointestinal or central nervous system hemorrhage; 7. Participation in a clinical trial of a similar type of drug within 4 weeks prior to enrollment; 8. Pregnant or lactating women; 9. Individuals with a history of allergy to the study drug; 10. Individuals deemed ineligible for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the proportion of patients with platelet counts <100 × 10^9/L during treatment cycles prevented by use of Herombopag Olamine Tablets.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients requiring platelet transfusion therapy during treatment;Median time to maintain platelet count =100 × 10^9/L from initiation of Herombopag Olamine Tablets to the end of the treatment cycle;The proportion of patients who experienced delayed initiation, dose reduction, or discontinuation of T-DM1 due to thrombocytopenia; | — |
Countries
China
Contacts
Public ContactZeng Yinduo
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed