Herombopag Treated T-DM1 Induced Platelet Reduction

A Multicenter, Single-arm Exploratory Clinical Study Evaluating the Efficacy and Safety of T-DM1 in Patients With Breast Cancer Who Developed Thrombocytopenia.

This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L) through intervention.

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia
• Intervention / Treatment: Drug: Herombopag Olamine Tablets

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tao Qin, MD; Phone Number: 86-02034071337; Email: qintao5471@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital
      • Contact: Tao Qin, MD; Phone Number: 86-02034071337; Email: qintao5471@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion：

• Age 18-75 years, any gender;
• Pathologically diagnosed with breast cancer based on histological or cytological examination, and previously treated with neoadjuvant anti-HER-2 therapy followed by T-DM1 adjuvant therapy;
• Experienced grade 2 or higher tumor treatment-related thrombocytopenia during the previous T-DM1 treatment cycle, with platelet count restored to ≥100 × 109/L and ≤200 × 109/L prior to the next treatment;
• ECOG performance status score: 0-2;
• Planned to undergo at least two additional treatment cycles including T-DM1 administration, with the dose of T-DM1 in the current cycle consistent with the previous cycle;
• Expected survival of ≥12 weeks and able to tolerate the current treatment regimen for at least two cycles or more;
• Expected to have good compliance, able to follow up on treatment efficacy and adverse reactions as required by the protocol.

Exclusion:

• A history of other malignant tumors diagnosed within the past 3 years;
• Patients with mental or neurological disorders who are unable to cooperate;
• Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplantation;
• Patients with hematopoietic system disorders other than chemotherapy-induced thrombocytopenia (CTIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome;
• Patients with a history of any arterial or venous thrombotic events within the past 6 months prior to screening;
• Severe bleeding manifestations within 2 weeks prior to screening, such as gastrointestinal or central nervous system bleeding;
• Participation in a clinical trial of the same type of drug within 4 weeks prior to enrollment;
• Pregnant or lactating women;
• Patients with a history of hypersensitivity to the study drug;
• Patients deemed ineligible by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; Herombopag， initial dose 7.5 mg po qd d1-14	Drug: Herombopag Olamine Tablets; Herombopag 7.5 mg po qd，d1-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of grade I thrombocytopenia according to CTCAE4.0	The proportion of patients with platelet counts <100 × 109/L according to CTCAE4.0	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportion of salvage platelet transfusion therapy	Proportion of patients requiring platelet transfusion therapy during treatment	From enrollment to the end of treatment at 6 weeks
time to platelet counts ≥100 × 109/L	Median time to achieve and maintain platelet counts ≥100 × 109/L from the start of Hetrombopag until the next treatment cycle;	From enrollment to the end of treatment at 6 weeks
Proportion of T-DM1with unexpected administration	Proportion of patients who experienced delay, dose reduction, or discontinuation of T-DM1 due to thrombocytopenia	From enrollment to the end of treatment at 6 weeks
proportion of adverse events	According to CTC AE 4.0 to evaluate profile of adverse events	From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Yinduo Zeng, MD, Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2027

Study Registration Dates

• First Submitted: September 3, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Hematologic Diseases; Blood Platelet Disorders; Hemic and Lymphatic Diseases; Thrombocytopenia
• Other Study ID Numbers: HQBP-IIT-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No