Actively Recruiting
A Multicenter, Single-arm Exploratory Study Evaluating Herombopag Safety and Efficacy in Breast Cancer Patients With T-DM1 Induced Thrombocytopenia
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-12-02
56
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Herombopag Treated T-DM1 Induced Platelet Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Pathological diagnosis of breast cancer by histology or cytology
- Prior treatment with neoadjuvant anti-HER-2 therapy followed by T-DM1 adjuvant therapy
- Experienced grade 2 or higher thrombocytopenia during previous T-DM1 cycle
- Platelet count restored to between 100 x 10^9/L and 200 x 10^9/L before next treatment
- ECOG performance status score of 0 to 2
- Plan to receive at least two more T-DM1 treatment cycles at consistent dosing
- Expected survival of at least 12 weeks
- Able to tolerate current treatment and comply with follow-up requirements
You will not qualify if you...
- History of other malignant tumors diagnosed within the past 3 years
- Mental or neurological disorders preventing cooperation
- Scheduled for or previous organ or bone marrow transplantation
- Hematopoietic system disorders other than chemotherapy-induced thrombocytopenia
- History of arterial or venous thrombotic events within past 6 months
- Severe bleeding within 2 weeks prior to screening
- Participation in a similar drug clinical trial within 4 weeks prior to enrollment
- Pregnant or breastfeeding women
- History of hypersensitivity to Herombopag
- Considered ineligible by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive Herombopag tablets daily for 14 days to treat T-DM1 induced thrombocytopenia.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
T
Tao Qin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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