Herombopag Treated T-DM1 Induced Platelet Reduction

NCT ID: NCT07257809

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2027-09-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group A

Herombopag， initial dose 7.5 mg po qd d1-14

Group Type: EXPERIMENTAL

Herombopag Olamine Tablets

Intervention Type: DRUG

Herombopag 7.5 mg po qd，d1-14

Interventions

Herombopag Olamine Tablets

Herombopag 7.5 mg po qd，d1-14

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Yinduo Zeng

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yinduo Zeng, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Qin, MD

Role: CONTACT

qintao5471@163.com

86-02034071337

Facility Contacts

Tao Qin, MD

Role: primary

qintao5471@163.com

86-02034071337

Other Identifiers

HQBP-IIT-2025

Identifier Type: -

Identifier Source: org_study_id