Herombopag Treated T-DM1 Induced Platelet Reduction

Sun Yat-sen University

Status and phase

Enrolling

Phase 2

Conditions

Thrombocytopenia

Treatments

Drug: Herombopag Olamine Tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT07257809

HQBP-IIT-2025

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.