Ado-trastuzumab emtansine (T-DM1) demonstrates favorable efficacy in breast cancer treatment but is frequently associated with thrombocytopenia. Multiple studies indicate that Asian populations face a higher risk of developing thrombocytopenia during T-DM1 therapy, with incidence rates ranging from 52.5% to 69.8% and ≥Grade 3 rates between 29.8% and 45.0%. Severe thrombocytopenia not only increases bleeding risks but may also necessitate T-DM1 dose delays or reductions, thereby compromising treatment efficacy and diminishing patient survival and quality of life. Herombopag selectively binds to the transmembrane region of TPO-R, activating TPO-R-dependent STAT and MAPK signaling pathways. This effectively stimulates megakaryocyte proliferation and differentiation, promoting thrombopoiesis. However, high-level evidence supporting the use of Herombopag for primary prevention of T-DM1-induced thrombocytopenia in breast cancer remains lacking.
Female, age ≥18 years;
Histopathologically or cytologically confirmed diagnosis of breast cancer;
Tumor tissue confirmed as HER2-positive, defined as immunohistochemistry (IHC) showing +++, or IHC++ with fluorescence in situ hybridization (FISH) demonstrating HER2-positive status;
Planned to receive T-DM1 regimen based on clinical judgment;
A confirmed history of severe allergic reactions to the active ingredients or excipients of the therapeutic drug;
Presence of other underlying diseases or comorbidities causing thrombocytopenia, such as aplastic anemia, immune thrombocytopenia, myelodysplastic syndrome, etc.;
Individuals with hereditary bleeding disorders, coagulation dysfunction, high bleeding risk, or a history of thrombotic events (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months prior to initial medication use;
Individuals with uncontrolled hypertension and a history of hypertensive crisis or hypertensive encephalopathy;
Single group
Herombopag
DrugEach T-DM1 treatment cycle typically lasts 3 weeks, with prophylactic administration of eltrombopag continuing until 21 days after the end of that T-DM1 treatment cycle. Oral administration of eltrombopag ethanolamine tablets begins on the evening of the first day of each T-DM1 treatment cycle, starting at a dose of 7.5 mg once daily.
Incidence of thrombocytopenia (<100 × 10⁹/L)
PLT \<100 × 10⁹/L
The time of the first occurrence of thrombocytopenia (<100 × 10⁹/L);
Time at which PLT \< 100 × 10⁹/L occurs
Incidence of AEs
Record the occurrence of adverse events during the study period
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Zhenzhen Liu
Lead sponsor
Henan Cancer Hospital
Sponsor institution
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