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

NCT07578064 | Recruiting Phase 4

• 1 other identifier: BC-NEU-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer; Bone Marrow Suppression

Outcome Measures

Primary Outcomes (1)

• Lowest neutrophil count (ANC) in the two stages

  Compare the lowest values of neutrophils (ANC) in each group during the two chemotherapy cycles

  From the initial treatment to the end of follow-up, approximately 42 or 56 days

Secondary Outcomes (6)

• Rate of ANC decline (Grade II/III/IV), duration of ANC decline in the two stages

  From the initial treatment to the end of follow-up, approximately 42 or 56 days

• Dosage of G-CSF

  From the initial treatment to the end of follow-up, approximately 42 or 56 days

• The incidence of febrile neutropenia

  From the initial treatment to the end of follow-up, approximately 42 or 56 days

• Infection incidence rate

  From the initial treatment to the end of follow-up, approximately 42 or 56 days

• Antibiotic utilization rate

  From the initial treatment to the end of follow-up, approximately 42 or 56 days

Study Arms (2)

Group A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the s

EXPERIMENTAL

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).

Drug: Group A

Group B: In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the secon

EXPERIMENTAL

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).

Drug: Group B

Interventions

Group A DRUG

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 A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the s

Group B DRUG

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).

Group B: In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the secon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Hongxia Wang: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hongxia wang, PhD

CONTACT

021-64175590; whx365@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: May 11, 2026
• Study Start: August 6, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2025-05

Locations

CN (1)