Primary Prevention of Thrombocytopenia Associated With T-DM1 Therapy in HER2 Positive Breast Cancer With Herombopag

Sponsor
Zhenzhen Liu
Study ID
NCT07198672
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 30, 2025
Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Herombopag Group
    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.

Primary Outcome Measure

Incidence of thrombocytopenia (<100 × 10⁹/L) [ Time Frame: up to 6 cycles (each cycle is 21 days) ]

Central Contacts

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