Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 2
Started
2025-10-13
Last updated
2025-12-02
Condition(s) studied
Thrombocytopenia
Investigational drug(s) / intervention(s)
Herombopag Olamine Tablets
Herombopag Olamine Tablets: Herombopag 7.5 mg po qd,d1-14
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of grade I thrombocytopenia according to CTCAE4.0 — From enrollment to the end of treatment at 6 weeks The proportion of patients with platelet counts \<100 × 109/L according to CTCAE4.0
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen Memorial Hospital
Guangzhou
Guangdong
Recruiting
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.