Comparing Shengbai oral liquid and Leucogen tablets for moderate chemotherapy‑related neutropenia in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, self‑controlled crossover study where participants are assigned 1:1 to two sequences: Shengbai oral liquid for one treatment cycle followed by Leucogen tablets for the next, or the reverse sequence. Dosing is Shengbai oral liquid 40 ml three times daily and Leucogen tablets 20 mg three times daily, with randomization stratified by early versus late stage disease. Eligible participants have histologically confirmed breast cancer and developed grade II–III neutropenia during ongoing anti‑tumor therapy, and will continue the same cancer treatment for at least two cycles while receiving the study interventions. The trial compares effects on neutrophil counts, safety, and the ability to continue planned cancer therapy without dose interruptions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age range: 18 to 80 years old, gender unrestricted;
2. Patients with breast cancer confirmed by histopathology.
3. ECOG performance status score ≤ 2; expected survival time ≥ 12 weeks;
4. 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.
5. 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;
6. The subject has high compliance and voluntarily signs the informed consent form.

Exclusion Criteria:

* 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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Hongxia wang, PhD
• Email: whx365@126.com
• Phone: 021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.