Exploring Herombopag Treatment for Breast Cancer Patients with T-DM1 Induced Low Platelet Counts Phase 2 Study to Assess Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Herombopag in breast cancer patients who developed thrombocytopenia, a condition of low platelet counts, following prior chemotherapy with T-DM1. This Phase 2, single-arm clinical study plans to enroll 56 patients who previously experienced grade 2 or higher thrombocytopenia but have since achieved platelet count normalization. Participants will receive Herombopag tablets at an initial dose of 7.5 mg daily for 14 days. The study will monitor the patients through at least two additional treatment cycles of T-DM1, maintaining consistent dosing. The treatment period lasts for 6 weeks, during which researchers will assess platelet counts and other related outcomes. Throughout the study, participants will undergo evaluations of platelet levels, adverse events, and the need for platelet transfusions. The primary outcome is the proportion of patients with grade 1 thrombocytopenia by the end of treatment. Safety and treatment adherence will be closely monitored, with follow-up visits scheduled according to the protocol. The total participation duration aligns with the treatment cycles and outcome assessments over 6 weeks.

Herombopag Treated T-DM1 Induced Platelet Reduction