NCT07257809 Herombopag Treated T-DM1 Induced Platelet Reduction
| NCT ID | NCT07257809 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2026-09-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 56 participants in total. It began in 2025-10-13 with a primary completion date of 2026-09-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Yinduo Zeng, MD
PRINCIPAL INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT07257809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07257809 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07257809 currently recruiting?
Yes, NCT07257809 is actively recruiting participants. Contact the research team at qintao5471@163.com for enrollment information.
Where is the NCT07257809 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07257809 clinical trial?
NCT07257809 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Yinduo Zeng, MD at Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 56 participants.