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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.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07257809
Enrollment
56
Registered
2025-12-02
Start date
2025-10-13
Completion date
2027-09-26
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia

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.

Interventions

Herombopag 7.5 mg po qd,d1-14

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of grade I thrombocytopenia according to CTCAE4.0From enrollment to the end of treatment at 6 weeksThe proportion of patients with platelet counts \<100 × 109/L according to CTCAE4.0

Secondary

MeasureTime frameDescription
the proportion of salvage platelet transfusion therapyFrom enrollment to the end of treatment at 6 weeksProportion of patients requiring platelet transfusion therapy during treatment
time to platelet counts ≥100 × 109/LFrom enrollment to the end of treatment at 6 weeksMedian time to achieve and maintain platelet counts ≥100 × 109/L from the start of Hetrombopag until the next treatment cycle;
Proportion of T-DM1with unexpected administrationFrom enrollment to the end of treatment at 6 weeksProportion of patients who experienced delay, dose reduction, or discontinuation of T-DM1 due to thrombocytopenia
proportion of adverse eventsFrom enrollment to the end of treatment at 6 weeksAccording to CTC AE 4.0 to evaluate profile of adverse events

Countries

China

Contacts

Primary ContactTao Qin, MD
qintao5471@163.com86-02034071337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026