Herombopag Treated T-DM1 Induced Platelet Reduction

NCT07257809 | Recruiting Phase 2

• 1 other identifier: HQBP-IIT-2025
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the proportion of salvage platelet transfusion therapy

  From enrollment to the end of treatment at 6 weeks

• time to platelet counts ≥100 × 109/L

  From enrollment to the end of treatment at 6 weeks

• Proportion of T-DM1with unexpected administration

  From enrollment to the end of treatment at 6 weeks

• proportion of adverse events

  From enrollment to the end of treatment at 6 weeks

Study Arms (1)

Treatment group A

EXPERIMENTAL

Herombopag， initial dose 7.5 mg po qd d1-14

Drug: Herombopag Olamine Tablets

Interventions

Herombopag Olamine Tablets DRUG

Herombopag 7.5 mg po qd，d1-14

Treatment group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Yinduo Zeng, MD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Qin, MD

CONTACT

86-02034071337; qintao5471@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: December 2, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-10

Locations

CN (1)