Breast CancerPhase 4NCT05871437
Randomized Controlled Clinical Study on the Reduction of Tumor Marker Levels in Breast Cancer Patients by Huaier Granules
A Phase 4 study testing Huaier granule in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the rate of reduction of tumor markers to normal levels in breast cancer patients treated with Huaier granules compared to the control group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Huaier granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Jan 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤ age ≤ 75 years old, regardless of gender.
- Postoperative pathological diagnosis of breast cancer.
- Imaging or pathological examination without evidence of recurrence or metastasis.
- If tumor markers are elevated, it is necessary to go to the corresponding department for medical treatment or issue a corresponding examination when necessary to exclude recurrence, metastasis or the second primary tumor of breast cancer.
- One or more tumor markers in CEA/CA125/CA153 exceed the upper limit of normal values.
- The liver and kidney functions meet the following conditions: AST and ALT< 3 ULN, total bilirubin ≤ 2 ULN, and blood creatinine<1.5 ULN;
Show all 9Show fewer
- Other laboratory tests meet the following requirements: Hb ≥ 9g/dl, platelet count ≥ 60 × 10^9/L, absolute neutrophil count>1.0 × 10^9/L.
- The patient's ECOG physical state score is 0 or 1.
- The subjects participated in this study voluntarily and signed an informed consent form.
Who cannot join
- Diagnosed as any other malignant tumor within the 5 years prior to enrollment, except for malignant tumors with low risk of metastasis and death (5-year survival rate>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ.
- Imaging or pathological confirmation of recurrence and metastasis.
- Serious infections (CTCAE>Level 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization; Symptoms and signs of infection or the need for oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, excluding the use of prophylactic antibiotics.
- Suffering from severe acute and chronic diseases.
- Suffering from severe diabetes whose blood sugar cannot be effectively controlled.
- Patients who are unable to take oral medication, those who are allergic to the ingredients of Huaier granules, and pregnant or lactating women.
- Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance.
- The researcher believes that it is not suitable to participate 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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhimin H Shao, PhD, +8618017312288, zhimingshao@yahoo.com
Liang Huang, PhD, +8618121299334, fdhlyx@163.com
About this study
Official title: Prospective, Multicenter, Randomized Controlled Clinical Trial on the Effect of Huaier Granules in Reducing Tumor Marker Levels in Patients With Early-Stage Breast Cancer
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the rate of reduction of tumor markers to normal levels in breast cancer patients treated with Huaier granules compared to the control group.
Read the detailed description
This study is a prospective, multicenter, randomized controlled clinical trial. Patients in the follow-up phase after breast cancer surgery were screened, excluding those with recurrence or metastasis, while having tumor markers (CEA/CA125/CA153) levels exceeding the upper limit of normal. A total of 232 patients were enrolled and randomly assigned to either the control group or the experimental group. They were followed up for one year, or until intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurred first; or until the investigator determined that no further benefit could be obtained.
During the entire study period, the planned patient recruitment and enrollment duration is approximately 12 months, with a total follow-up duration of 12 months per participant. After enrollment, patients will be followed up every three months until the study concludes, or until the patient withdraws from the study for any reason or passes away.
- Conditions
- Breast Cancer
- Being tested
- Huaier granule
- Keywords
- Huaier granule, breast cancer, level of tumor markers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier granuleDrug
Also called Z20000109（NMPA Approval Number）
On the basis of routine clinical treatment/follow-up, take Huaier Granules orally, 10g each time, three times a day, for one year continuously or until disease progression, intolerable toxicity, withdrawal from the study for any reason or death occurs, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Huaier Granule+Conventional clinical therapeutic drugs | Experimental | Huai er Granules: Oral administration, 10g each time, three times a day, for one year. In case of intolerable toxicity, withdrawal from the study for any reason, or death, the first occurrence shall prevail. Or the researchers determine that they will no longer benefit. For specific usage, please refer to the drug instructions. For specific usage, please refer to the drug instructions. Receives: Drug: Huaier granule |
| Conventional clinical therapeutic drugs | No intervention | Treatment and follow-up were carried out in accordance with clinical routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate of any tumor marker (CEA/CA125/CA153) to normal
The rate at which one or more tumor markers (CEA/CA125/CA153) exceed the upper limit of normal values before patient enrollment and any tumor marker that rises before enrollment decreases to the normal range after the end of Huaier Granule treatment
Measured: Start of treatment until 2-year follow-up
Secondary outcomes (3)
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
The definition and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of adverse events, and the incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population
Measured: Start of treatment until 2-year follow-up
The incidence and severity of adverse reaction (ADR), severe adverse reactions(SADR), suspicious and unexpected severe adverse reaction (SUSAR)
The definition and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of adverse events. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population
Measured: Start of treatment until 2-year follow-up
Quality of Life Score
Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.
Measured: Start of treatment until 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study startSep 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2028 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871437
- Sponsor's protocol ID
- HE- 202504
- Status last verified
- Sep 2025
- First submitted
- 4 May 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Clinical Trial on the Effect of Huaier Granules in Reducing Tumor Marker Levels in Patients With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05871437
- Acronym / sponsor ID
- HE- 202504
- Conditions
- Breast Cancer
- Keywords
- Huaier granule, breast cancer, level of tumor markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 May 2023 (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.
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the rate of reduction of tumor markers to normal levels in breast cancer patients treated with Huaier granules compared to the control group.
Detailed description
This study is a prospective, multicenter, randomized controlled clinical trial. Patients in the follow-up phase after breast cancer surgery were screened, excluding those with recurrence or metastasis, while having tumor markers (CEA/CA125/CA153) levels exceeding the upper limit of normal. A total of 232 patients were enrolled and randomly assigned to either the control group or the experimental group. They were followed up for one year, or until intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurred first; or until the investigator determined that no further benefit could be obtained.
During the entire study period, the planned patient recruitment and enrollment duration is approximately 12 months, with a total follow-up duration of 12 months per participant. After enrollment, patients will be followed up every three months until the study concludes, or until the patient withdraws from the study for any reason or passes away.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier Granule+Conventional clinical therapeutic drugs | Experimental | Drug: Huaier granuleHuai er Granules: Oral administration, 10g each time, three times a day, for one year. In case of intolerable toxicity, withdrawal from the study for any reason, or death, the first occurrence shall prevail. Or the researchers determine that they will no longer benefit. For specific usage, please refer to the drug instructions. For specific usage, please refer to the drug instructions. |
| Conventional clinical therapeutic drugs | No intervention | –Treatment and follow-up were carried out in accordance with clinical routines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 ≤ age ≤ 75 years old, regardless of gender.
- Postoperative pathological diagnosis of breast cancer.
- Imaging or pathological examination without evidence of recurrence or metastasis.
- If tumor markers are elevated, it is necessary to go to the corresponding department for medical treatment or issue a corresponding examination when necessary to exclude recurrence, metastasis or the second primary tumor of breast cancer.
- One or more tumor markers in CEA/CA125/CA153 exceed the upper limit of normal values.
Key exclusion criteria (8 listed)
- Diagnosed as any other malignant tumor within the 5 years prior to enrollment, except for malignant tumors with low risk of metastasis and death (5-year survival rate>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ.
- Imaging or pathological confirmation of recurrence and metastasis.
- Serious infections (CTCAE>Level 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization; Symptoms and signs of infection or the need for oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, excluding the use of prophylactic antibiotics.
- Suffering from severe acute and chronic diseases.
- Suffering from severe diabetes whose blood sugar cannot be effectively controlled.
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 |
|---|---|---|
| Huaier granuleAlso: Z20000109（NMPA Approval Number）On the basis of routine clinical treatment/follow-up, take Huaier Granules orally, 10g each time, three times a day, for one year continuously or until disease progression, intolerable toxicity, withdrawal from the study for any reason or death occurs, whichever occurs first. | Drug | Huaier Granule+Conventional clinical therapeutic drugs |
Primary outcome
Recovery rate of any tumor marker (CEA/CA125/CA153) to normal
Time frame: Start of treatment until 2-year follow-up
The rate at which one or more tumor markers (CEA/CA125/CA153) exceed the upper limit of normal values before patient enrollment and any tumor marker that rises before enrollment decreases to the normal range after the end of Huaier Granule treatment
3 secondary outcomes
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Time frame: Start of treatment until 2-year follow-up
The incidence and severity of adverse reaction (ADR), severe adverse reactions(SADR), suspicious and unexpected severe adverse reaction (SUSAR)
Time frame: Start of treatment until 2-year follow-up
Quality of Life Score
Time frame: Start of treatment until 2-year follow-up
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 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Zhimin Shao, PhD principal investigator
Fudan University
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 Huaier granule in people with Breast Cancer, run by Fudan University 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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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 Zhimin Shao, PhD (+8618017312288, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery rate of any tumor marker (CEA/CA125/CA153) to normal (time frame: Start of treatment until 2-year follow-up). 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 8 Sep 2025.