Breast Cancer Stage IVPhase 4NCT05860907
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
A Phase 4 study testing Huaier Granule in people with Breast Cancer Stage IV, run by Fudan University at 13 sites in China.
Trial summary
This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer Stage IV
- What is being tested?
- Huaier Granule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 13 sitesChina
- Study dates
- Oct 2023to Oct 2027
- 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 years old ≤ age ≤ 75, regardless of gender.
- For breast cancer patients who are clinically or pathologically diagnosed as non visceral metastasis, if the patient has only local recurrence or metastasis, the clinician judges that it is not suitable or refuses to use local treatment with radical intensity, such as surgical resection or radiotherapy.
- Prior to enrollment, no more than first-line chemotherapy/endocrine therapy/targeted therapy/immunotherapy were allowed;If the patient has previously received first-line therapy, the outcome of treatment should be clinically assessed as disease progression or intolerance.
- There is at least one measurable lesion that meets the RECIST 1.1 standard, or only bone metastases (including osteolytic lesions or mixed lesions).
- The liver and kidney functions meet the following conditions: AST and ALT<3 ULN, total bilirubin ≤ 2 ULN, and blood creatinine<1.5 ULN.
- Other laboratory tests meet the following requirements: Hb ≥ 9g/dl, platelet count ≥ 60 × 10^9/L, absolute neutrophil count>1.0 × 10^9/L.
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- Expected survival time ≥ 12 weeks.
- The patient's ECOG physical state score is 0 or 1.
- The subjects participated in the study voluntarily and signed an informed consent form.
Who cannot join
- Any other malignancies diagnosed within 5 years prior to enrollment, except those with a low risk of metastasis and death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
- There is visceral metastasis of breast cancer.
- Patients with advanced (local recurrence or metastasis) breast cancer who plan to receive radical local treatment.
- Serious infections (CTCAE>Level 2) have occurred within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, 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, except for prophylactic use of antibiotics.
- Suffering from severe acute and chronic diseases.
- Suffering from severe diabetes whose blood sugar cannot be effectively controlled.
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- Patients who cannot take oral medication or are allergic to the ingredients of Huaier granules.
- Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance.
- Pregnant or lactating women.
- The researcher believes that it is not suitable to participate in this study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410011
Jinhui Hu, PhD, +8613637412178
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Boni Ding, PhD, +8613627418663
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Xiaojia Wang, PhD, +8613906500190
The First Hospital of Jiaxin
Jiaxin, Zhejiang, 314000
Caiping Chen, PhD, +8613967370819
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323020
Shuzheng Chen, PhD, +8613567618556
Nantong First People's Hospital
Nantong, Jiangsu, 226006
Jinpeng Chen, PhD, +8618551315594
The International Peace Maternity & Child Health Hospital of China welfare institute
Shanghai, Shanghai Municipality, 200030
Jie Wang, PhD, +8618017316231
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, PhD, +8618017312288, zhimingshao@yahoo.com
Liang Huang, PhD, +8618121299334, fdhlyx@163.com
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Baosan Han, PhD, +8618017312288
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Li Ma, PhD, +8613932116886
Taizhou Central Hospital
Taizhou, Zhejiang, 318001
Yuechu Dai, PhD, +8613906768336
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Deyuan Fu, PhD, +8618051060677
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xin Ge, PhD, +8613303719081
About this study
Official title: A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.
Read the detailed description
This study used a blank control design and included at least 384 subjects. The experimental group and control group were randomized in a 2:1 ratio (at least 256 subjects in the experimental group and at least 128 subjects in the control group). Patients in the experimental group were treated with Huaier Granules (10g/dose, 3 times/day), while undergoing routine diagnosis and treatment; The control group received routine diagnosis and treatment, but did not take Huaier granules until the subjects experienced disease progression or intolerance.
- Conditions
- Breast Cancer Stage IV
- Being tested
- Huaier Granule
- Keywords
- non-visceral metastasis, Huaier granule, randomized controlled, prospective clinical study
- 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）
10g each time, three times a day
| Study group | Role | What they receive |
|---|---|---|
| Huaier Granule+Standard treatment | Experimental | The subject is administered according to the clinical dosage and method of medication until disease progression occurs or the subject is unable to tolerate treatment.Subjects receiving routine diagnosis and treatment simultaneously. Receives: Drug: Huaier Granule |
| Standard treatment | No intervention | Subjects receive routine diagnosis and treatment without taking Huaier granules. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator evaluated progression free survival
The time from randomization to the first occurrence of disease progression or death from any cause. As long as the subject experiences either "disease progression" or "death" first, it reaches the endpoint of the study
Measured: start of treatment until 3.5-year follow-up
Secondary outcomes (4)
Overall survival(OS)
The time from randomization to death (from any cause)
Measured: start of treatment until 3.5-year follow-up
Clinical benefit rate (CBR)
The percentage of patients with advanced breast cancer who achieved a complete response, partial response, or stable disease for at least six months after treatment
Measured: start of treatment until 3.5-year follow-up
Objective response rate (ORR)
Proportion of patients whose breast cancer has shrunk to a predetermined volume and maintains a minimum time limit
Measured: start of treatment until 3.5-year follow-up
Adverse reactions
Harmful reactions of Huaier granules that are unrelated to the purpose of the medication under normal usage and dosage
Measured: start of treatment until 3.5-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 posted16 May 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies 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
- None (open label)
- Enrolment
- 384 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, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860907
- Sponsor's protocol ID
- HE-202210-01
- Status last verified
- Sep 2023
- First submitted
- 5 May 2023
- Last updated
- 26 Sep 2023
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
- ClinicalTrials.gov ID
- NCT05860907
- Acronym / sponsor ID
- HE-202210-01
- Conditions
- Breast Cancer Stage IV
- Keywords
- non-visceral metastasis, Huaier granule, randomized controlled, prospective clinical study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 16 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 is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.
Detailed description
This study used a blank control design and included at least 384 subjects. The experimental group and control group were randomized in a 2:1 ratio (at least 256 subjects in the experimental group and at least 128 subjects in the control group). Patients in the experimental group were treated with Huaier Granules (10g/dose, 3 times/day), while undergoing routine diagnosis and treatment; The control group received routine diagnosis and treatment, but did not take Huaier granules until the subjects experienced disease progression or intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier Granule+Standard treatment | Experimental | Drug: Huaier GranuleThe subject is administered according to the clinical dosage and method of medication until disease progression occurs or the subject is unable to tolerate treatment.Subjects receiving routine diagnosis and treatment simultaneously. |
| Standard treatment | No intervention | –Subjects receive routine diagnosis and treatment without taking Huaier granules. |
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 years old ≤ age ≤ 75, regardless of gender.
- For breast cancer patients who are clinically or pathologically diagnosed as non visceral metastasis, if the patient has only local recurrence or metastasis, the clinician judges that it is not suitable or refuses to use local treatment with radical intensity, such as surgical resection or radiotherapy.
- Prior to enrollment, no more than first-line chemotherapy/endocrine therapy/targeted therapy/immunotherapy were allowed;If the patient has previously received first-line therapy, the outcome of treatment should be clinically assessed as disease progression or intolerance.
- There is at least one measurable lesion that meets the RECIST 1.1 standard, or only bone metastases (including osteolytic lesions or mixed lesions).
- The liver and kidney functions meet the following conditions: AST and ALT<3 ULN, total bilirubin ≤ 2 ULN, and blood creatinine<1.5 ULN.
Key exclusion criteria (10 listed)
- Any other malignancies diagnosed within 5 years prior to enrollment, except those with a low risk of metastasis and death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
- There is visceral metastasis of breast cancer.
- Patients with advanced (local recurrence or metastasis) breast cancer who plan to receive radical local treatment.
- Serious infections (CTCAE>Level 2) have occurred within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, 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, except for prophylactic use of antibiotics.
- Suffering from severe acute and chronic diseases.
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）10g each time, three times a day | Drug | Huaier Granule+Standard treatment |
Primary outcome
Investigator evaluated progression free survival
Time frame: start of treatment until 3.5-year follow-up
The time from randomization to the first occurrence of disease progression or death from any cause. As long as the subject experiences either "disease progression" or "death" first, it reaches the endpoint of the study
4 secondary outcomes
Overall survival(OS)
Time frame: start of treatment until 3.5-year follow-up
Clinical benefit rate (CBR)
Time frame: start of treatment until 3.5-year follow-up
Objective response rate (ORR)
Time frame: start of treatment until 3.5-year follow-up
Adverse reactions
Time frame: start of treatment until 3.5-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 26 Sep 2023.
- Individual participant dataSharing planned: No
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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, Professor principal investigator
Fudan University
13 sites 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 Stage IV, run by Fudan University at 13 sites 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 10 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Investigator evaluated progression free survival (time frame: start of treatment until 3.5-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 26 Sep 2023.