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Herombopag Treated T-DM1 Induced Platelet Reduction

RecruitingPhase 2Ages 18 Years - 75 YearsAllSun Yat-Sen Memorial Hospital of Sun Yat-Sen Univ…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Herombopag Olamine Tablets
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Where

1 site
Sun Yat-sen Memorial Hospital
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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