A Randomized, Self-controlled Post-marketing Clinical Study on the Comparison of Shengbai Oral Liquid and Leucogen Tablets in the Treatment of Moderate Neutropenia Caused by Anti-tumor Drugs in Breast Cancer Patients

Обзор

The subjects were randomly assigned to Group A or Group B in a 1:1 ratio, stratified by early/late stage. Group A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the second cycle, they took Leucogen Tablets (20 mg, three times a day). Group B: In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the second cycle, they took Shengbai Oral Liquid (40 ml, three times a day).

Вмешательства

• Препарат Group A
  In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the second cycle, they took Leucogen Tablets (20 mg, three times a day).
• Препарат Group B
  In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the second cycle, they took Shengbai Oral Liquid (40 ml, three times a day).

Первичные конечные точки

• Lowest neutrophil count (ANC) in the two stages [Срок оценки: From the initial treatment to the end of follow-up, approximately 42 or 56 days]

Вторичные конечные точки (6)

• Rate of ANC decline (Grade II/III/IV), duration of ANC decline in the two stages [Срок оценки: From the initial treatment to the end of follow-up, approximately 42 or 56 days]
• Dosage of G-CSF [Срок оценки: From the initial treatment to the end of follow-up, approximately 42 or 56 days]
• The incidence of febrile neutropenia [Срок оценки: From the initial treatment to the end of follow-up, approximately 42 or 56 days]
• Infection incidence rate [Срок оценки: From the initial treatment to the end of follow-up, approximately 42 or 56 days]
• Antibiotic utilization rate [Срок оценки: From the initial treatment to the end of follow-up, approximately 42 or 56 days]
• The completion rate of anti-tumor drugs [Срок оценки: From the initial treatment to the end of follow-up, approximately 42 or 56 days]

Критерии участия

Критерии включения

• Age range: 18 to 80 years old, gender unrestricted;
• Patients with breast cancer confirmed by histopathology.
• ECOG performance status score ≤ 2; expected survival time ≥ 12 weeks;
• During the period of anti-tumor drug treatment before enrollment (including but not limited to chemotherapy drugs: paclitaxel, capecitabine, vinorelbine; CDK4/6 inhibitors: palbociclib, dalpiciclib, ribociclib, abemaciclib; antibody-drug conjugates: trastuzumab emtansine, trastuzumab deruxtecan, sacituzumab govitecan, larotrectinib), grade II-III neutropenia occurred, and it is planned to continue the original treatment plan and dose for at least 2 cycles.
• The subject meets the criteria for continuing anti-tumor drug treatment; normal bone marrow hematopoietic function, no bleeding tendency (INR < 1.5); blood routine meets the following requirements: Hb ≥ 8g/dl, platelet count ≥ 75×109/L; liver and kidney function meets the following requirements: AST and ALT ≤ 3 ULN, total bilirubin ≤ 2 ULN, serum creatinine ≤ 1.5 ULN; no obvious heart and lung function disorders;
• The subject has high compliance and voluntarily signs the informed consent form.

Критерии исключения

• 1\. Having participated in other new drug clinical trials within 4 weeks before enrollment; planning to participate in other new drug clinical trials during the study period; planning to add other anti-tumor treatments during the study period; 2. Having received bone marrow radiotherapy involving 25% of the bone marrow; having undergone hematopoietic stem cell transplantation or bone marrow transplantation; 3. Uncontrolled acute or chronic infection; having severe underlying diseases such as heart, lung, liver or kidney diseases; having primary diseases of the hematopoietic system; having diseases such as hypersplenism, hyperthyroidism, adrenal insufficiency, connective tissue diseases, etc. that can cause a decrease in white blood cells; 4. Uncontrolled digestive system symptoms that affect the administration of the study drug; confirmed or suspected allergy to the study drug or its related components; 5. Uncontrolled psychological or mental disorders; judged by the investigator as unsuitable for participation in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07578064 · BC-NEU-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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