Herombopag Treated T-DM1 Induced Platelet Reduction

Официальное название

A Multicenter, Single-arm Exploratory Clinical Study Evaluating the Efficacy and Safety of T-DM1 in Patients With Breast Cancer Who Developed Thrombocytopenia.

Обзор

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.

Вмешательства

• Препарат Herombopag Olamine Tablets
  Herombopag 7.5 mg po qd，d1-14

Первичные конечные точки

• Proportion of grade I thrombocytopenia according to CTCAE4.0 [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Вторичные конечные точки (4)

• the proportion of salvage platelet transfusion therapy [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• time to platelet counts ≥100 × 109/L [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Proportion of T-DM1with unexpected administration [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• proportion of adverse events [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Memorial Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07257809 · HQBP-IIT-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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