This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT.
Breast cancer patients with histologically or cytologically confirmed disease were enrolled after signing the informed consent form and were randomly assigned in a 1:1:1 ratio to three Arms. Stratification factors for randomization included the number of prior antineoplastic treatment cycles (\>2 cycles vs. ≤2 cycles).
Arm 1: No prophylactic use of hetrombopag Arm 2: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Arm 3: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle; Treatment continued until patients completed the protocol-specified treatment and follow-up, experienced intolerable toxicity, withdrew informed consent, initiated alternative antitumor therapy, died, or met any other treatment discontinuation criteria specified in the protocol, whichever occurred first.
Age ≥ 18 years;
Patients with histopathologically confirmed breast cancer;
Receiving or expected to receive chemotherapy-based antitumor therapy with a cycle length of ≥21 days, and anticipated to receive ≥2 cycles of therapy;
ECOG performance status 0-2;
Presence of hematological disorders, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes;
Uncontrolled active infection;
History of arterial or venous thrombosis;
Patients with bleeding tendency, or evidence of inherited bleeding diathesis or coagulation disorders;
Parallel
Continuous Hetrombopag for 2 Cycles
DrugHetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle
Cyclic 14-day Hetrombopag for 2 Cycles
DrugHetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle
Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Duration of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Incidence and duration of grade ≥3 thrombocytopenia (PLT < 50×10⁹/L)
Proportion of patients who successfully completed two chemotherapy cycles without thrombocytopenia-related modifications to subsequent antineoplastic therapy
Proportion of patients without rescue therapy for thrombocytopenia (e.g., platelet transfusion, interleukin-11, recombinant human thrombopoietin)
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