Breast CancerPhase 4NCT07578064
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
A Phase 4 study testing Group A and Group B in people with Breast Cancer and Bone Marrow Suppression, run by Hongxia Wang at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Bone Marrow Suppression
- What is being tested?
- Group A and Group B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
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
- Being tested
- Group A, Group B
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADrug
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 BDrug
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest neutrophil count (ANC) in the two stages
Compare the lowest values of neutrophils (ANC) in each group during the two chemotherapy cycles
Measured: 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
Compare the decline rates of grade II /III /IV ANC and the duration of ANC decline in each group during two chemotherapy cycles
Measured: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Dosage of G-CSF
Compare the dosage of G-SCF in each group during the two chemotherapy cycles
Measured: From the initial treatment to the end of follow-up, approximately 42 or 56 days
The incidence of febrile neutropenia
Compare the incidence of febrile neutropenia in each group during two chemotherapy cycles
Measured: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Infection incidence rate
Compare the incidence of infection in each group during the two chemotherapy cycles
Measured: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Antibiotic utilization rate
Compare the utilization rate of antibiotics in each group during the two chemotherapy cycles
Measured: From the initial treatment to the end of follow-up, approximately 42 or 56 days
The completion rate of anti-tumor drugs
Compare the completion rates of anti-tumor drugs in each group during the two chemotherapy cycles
Measured: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start6 Aug 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongxia Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongxia Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578064
- Sponsor's protocol ID
- BC-NEU-001
- Status last verified
- May 2025
- First submitted
- 29 Jul 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07578064
- Acronym / sponsor ID
- BC-NEU-001
- Conditions
- Breast Cancer, Bone Marrow Suppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hongxia WangUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the s | Experimental | Drug: Group AIn 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 secon | Experimental | Drug: Group BIn 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AIn 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 s |
| Group BIn 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 secon |
Primary outcome
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
6 secondary outcomes
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
Dosage of G-CSF
Time frame: 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
Infection incidence rate
Time frame: 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
The completion rate of anti-tumor drugs
Time frame: From the initial treatment to the end of follow-up, approximately 42 or 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Related trials for Breast Cancer
Not yet recruiting
Decision Support for Chemoprevention
Breast Cancer
Active, not recruiting
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruiting
Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer
Breast Cancer
Active, not recruitingObservational study
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Breast Cancer, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group A and Group B in people with Breast Cancer and Bone Marrow Suppression, run by Hongxia Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxia wang, PhD (021-64175590 ext. 13524491606, whx365@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.