A Phase 2 interventional study of Continuous Hetrombopag for 2 Cycles and Cyclic 14-day Hetrombopag for 2 Cycles in Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT), sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 126 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Platelet count meeting **one** of the following criteria:
Adequate organ function:
Bone marrow: ANC ≥ 1.5×10⁹/L; hemoglobin ≥ 8 g/dL;
Hepatic and renal function: total bilirubin ≤ 1.5 × ULN; ALT, AST ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastasis); serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault formula);
Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, not be breastfeeding, and agree to use effective contraception during the study and for 7 days after the last dose of study drug.
Male subjects with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 7 days after the last dose of study drug; sperm donation is prohibited during the study;
Voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to comply with follow-up procedures.
Exclusion Criteria:
No prophylactic use of hetrombopag
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
Drug: Continuous Hetrombopag for 2 Cycles
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
Drug: Cyclic 14-day Hetrombopag for 2 Cycles
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
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
Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Duration of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Incidence and duration of grade ≥3 thrombocytopenia (PLT < 50×10⁹/L)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients who successfully completed two chemotherapy cycles without thrombocytopenia-related modifications to subsequent antineoplastic therapy
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients without rescue therapy for thrombocytopenia (e.g., platelet transfusion, interleukin-11, recombinant human thrombopoietin)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Nadir and peak platelet counts
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Incidence of adverse events
Time frame: From enrollment to 21 days after the last dose of study drug
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Fudan University