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NOT YET RECRUITING
NCT07198672
NA

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

Sponsor: Zhenzhen Liu

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Single-arm, Exploratory Clinical Study of Herombopag Olamine Tablets for the Primary Prevention of Treatment-related Thrombocytopenia in HER2-positive Breast Cancer Patients Receiving T-DM1 Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-10-31

Completion Date

2028-10-31

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DRUG

Herombopag

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.