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

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

This study tests whether Shengbai oral liquid or Leucogen tablets work better to treat moderate neutropenia in people with breast cancer who are receiving anti‑tumor drugs.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Fudan University (other)
• Drugs / interventions: trastuzumab, sacituzumab, larotrectinib, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07578064 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (18–80 years) with histologically confirmed breast cancer, ECOG ≤2, expected survival ≥12 weeks, who developed grade II–III neutropenia while on anti‑tumor drugs and meet routine lab criteria for continued treatment.

Not a fit: Patients with severe or refractory bone marrow failure, active bleeding tendency, markedly abnormal liver/kidney function, or who do not meet the study lab or treatment continuation criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify a convenient oral medication that helps increase neutrophil counts and reduce chemotherapy interruptions for affected patients.

How similar studies have performed: There are prior post‑marketing and small clinical reports suggesting benefit of these agents for chemotherapy‑induced neutropenia, but direct randomized crossover comparisons are limited.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Hongxia wang, PhD

Conditions: Breast Cancer, Bone Marrow Suppression