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

May 4, 2026 updated by: Hongxia Wang
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongxia wang, PhD
  • Phone Number: 13524491606 021-64175590
  • Email: whx365@126.com

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the s
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
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).
Experimental: Group B: In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the secon
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lowest neutrophil count (ANC) in the two stages
Time Frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ANC decline (Grade II/III/IV), duration of ANC decline in the two stages
Time Frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Compare the decline rates of grade II /III /IV ANC and the duration of ANC decline in each group during two chemotherapy cycles
From the initial treatment to the end of follow-up, approximately 42 or 56 days
Dosage of G-CSF
Time Frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Compare the dosage of G-SCF in each group during the two chemotherapy cycles
From the initial treatment to the end of follow-up, approximately 42 or 56 days
The incidence of febrile neutropenia
Time Frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Compare the incidence of febrile neutropenia in each group during two chemotherapy cycles
From the initial treatment to the end of follow-up, approximately 42 or 56 days
Infection incidence rate
Time Frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Compare the incidence of infection in each group during the two chemotherapy cycles
From the initial treatment to the end of follow-up, approximately 42 or 56 days
Antibiotic utilization rate
Time Frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Compare the utilization rate of antibiotics in each group during the two chemotherapy cycles
From the initial treatment to the end of follow-up, approximately 42 or 56 days
The completion rate of anti-tumor drugs
Time Frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Compare the completion rates of anti-tumor drugs in each group during the two chemotherapy cycles
From the initial treatment to the end of follow-up, approximately 42 or 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongxia Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 29, 2025

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-NEU-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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