NCT07243418

Hetrombopag for the Prevention of ADC-Induced Thrombocytopenia in Breast Cancer: An Exploratory, Dual-Cohort, Phase 2 Study

Dual-cohort, Single-arm, Exploratory Phase II Clinical Study of Hetrombopag for Primary/Secondary Prevention of Thrombocytopenia Induced by ADC Drugs in Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The title of this study is: A two-cohort, single-arm, exploratory Phase II clinical study on the primary/secondary prevention ADC drug of heltrombopag for thrombocytopenia caused by breast cancer. This study is a two-cohort, single-arm, open-label, exploratory clinical trial for the prevention of thrombocytopenia caused by ADC drug treatment for breast cancer. This research was supported by Fujian Cancer Hospital. The protocol has been reviewed by the Ethics Committee of Fujian Cancer Hospital, which has agreed to conduct this clinical study.

Conditions

• CTIT-Chemotherapy Induced Thrombocytopenia
• Breast Cancer

Interventions

Type	Name	Description
DRUG	herombopag olamine tablets	Starting from day 1 after chemotherapy, oral administration ofherombopag olamine tablets at a dose of 5mg per day (the initial dose) was administered for 14 consecutive days. Blood routine tests of the subjects were collected on days 7, 10, and 14 respectively, and the dose of herombopag olamine tablets was adjusted according to PLT

Timeline

• Start date: 2025-11-30
• Primary completion: 2027-11-30
• Completion: 2028-05-30
• First posted: 2025-11-21
• Last updated: 2025-11-21