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
Recruiting
Phase 4
Interventional Study
Breast Cancer
Bone Marrow Suppression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Hongxia Wang · Other
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About This Trial
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 Shengba…
Trial Locations
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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 limi…
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