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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herombopag Group | Experimental | Preventive treatment with eltrombopag should be initiated on the evening of the first day of each T-DM1 treatment cycle (typically 3 weeks). Eltrombopag 7.5 mg (initial dose) should be administered orally once daily for a maximum duration of 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herombopag | Drug | Each 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of thrombocytopenia (<100 × 10⁹/L) | PLT <100 × 10⁹/L | up to 6 cycles (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The time of the first occurrence of thrombocytopenia (<100 × 10⁹/L); | Time at which PLT < 100 × 10⁹/L occurs | up to 6 cycles (each cycle is 21 days) |
| Incidence of AEs | Record the occurrence of adverse events during the study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhenzhen Liu, M.D. | Contact | 13603862755 | zlyyliuzhenzhen0800@zzu.edu.cn |
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| up to 6 cycles (each cycle is 21 days) |