Actively Recruiting
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
Led by Hongxia Wang · Updated on 2026-05-11
60
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Breast cancer confirmed by histopathology
- ECOG performance status score of 2 or less
- Expected survival time of at least 12 weeks
- Moderate neutropenia (grade II-III) during anti-tumor drug treatment including chemotherapy, CDK4/6 inhibitors, or antibody-drug conjugates
- Planning to continue original anti-tumor treatment and dose for at least 2 cycles
- Normal bone marrow hematopoietic function and no bleeding tendency (INR < 1.5)
- Blood tests: hemoglobin 8 g/dl or higher, platelet count 75 x 10^9/L or higher
- Liver and kidney function within specified limits (AST and ALT ≤ 3 times ULN, total bilirubin ≤ 2 times ULN, serum creatinine ≤ 1.5 times ULN)
- No significant heart or lung function disorders
- High compliance and voluntary informed consent
You will not qualify if you...
- Participation in other new drug clinical trials within 4 weeks before enrollment or planned during the study
- Planning to add other anti-tumor treatments during the study
- Received bone marrow radiotherapy involving 25% of bone marrow
- History of hematopoietic stem cell or bone marrow transplantation
- Uncontrolled acute or chronic infection
- Severe heart, lung, liver, or kidney diseases
- Primary hematopoietic system diseases
- Conditions causing white blood cell decrease such as hypersplenism, hyperthyroidism, adrenal insufficiency, connective tissue diseases
- Uncontrolled digestive symptoms affecting study drug administration
- Confirmed or suspected allergy to study drugs or components
- Uncontrolled psychological or mental disorders
- Investigator judgment deeming participant unsuitable for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
H
Hongxia wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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