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Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 2, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07647029). This is a study registration, not published results. Lead sponsor: Fudan University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 126 participants (ESTIMATED). Conditions: Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT). Interventions: DRUG: Continuous Hetrombopag for 2 Cycles; DRUG: Cyclic 14-day Hetrombopag for 2 Cycles. Primary outcome measures: Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L) , At the end of Cycle 2 (each cycle ≥21 days). Brief summary: 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.