RecruitingPhase 2NCT07257809
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.
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
56 participants
Start Date
Oct 13, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria10
- 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.
Interventions
DRUGHerombopag Olamine Tablets
Herombopag 7.5 mg po qd，d1-14
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07257809