The title of this study is: A two-cohort, single-arm, exploratory Phase II clinical study on the primary/secondary prevention ADC drug of heltrombopag for thrombocytopenia caused by breast cancer. This study is a two-cohort, single-arm, open-label, exploratory clinical trial for the prevention of thrombocytopenia caused by ADC drug treatment for breast cancer. This research was supported by Fujian Cancer Hospital. The protocol has been reviewed by the Ethics Committee of Fujian Cancer Hospital, which has agreed to conduct this clinical study.
1. Age: 18 -75 years old, gender not limited.
2. Breast cancer patients diagnosed by histopathological or cytological examination;
3. Cohort 1: Planned to receive ADC drug treatment; Cohort 2: Patients who received ADC drug treatment in the previous chemotherapy cycle and had a minimum PLT value of less than 75*109/L are expected to maintain the same chemotherapy regimen for ≥2 cycles.
4. Expected survival period ≥12 weeks;
1. Screening or baseline platelet value ≤10×109/L;
2. Patients who are currently taking pyrotinib, dalciclib or other CDK4/6 class drugs
3. Thrombocytopenia caused by non-tumor treatment occurred within 6 months before screening, including but not limited to liver cirrhosis with hypersplenism, infection and bleeding, etc.
4. Suffering from other hematopoietic system diseases except for thrombocytopenia caused by anti-tumor therapy, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma and myelodysplastic syndrome, etc.
Single group
herombopag olamine tablets
DrugStarting from day 1 after chemotherapy, oral administration ofherombopag olamine tablets at a dose of 5mg per day (the initial dose) was administered for 14 consecutive days. Blood routine tests of the subjects were collected on days 7, 10, and 14 respectively, and the dose of herombopag olamine tablets was adjusted according to PLT
The incidence rate of Grade 3 and above Cancer Therapy - Induced Thrombocytopenia (CTIT)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
