NCT05860907

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for phase_4

Timeline
17mo left

Started Oct 2023

Longer than P75 for phase_4

Geographic Reach
1 country

13 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Oct 2023Oct 2027

First Submitted

Initial submission to the registry

May 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

May 5, 2023

Last Update Submit

September 22, 2023

Conditions

Breast Cancer Stage IV

Keywords

non-visceral metastasisHuaier granulerandomized controlledprospective clinical study

Outcome Measures

Primary Outcomes (1)

  • 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

    start of treatment until 3.5-year follow-up

Secondary Outcomes (4)

  • Overall survival(OS)

    start of treatment until 3.5-year follow-up

  • Clinical benefit rate (CBR)

    start of treatment until 3.5-year follow-up

  • Objective response rate (ORR)

    start of treatment until 3.5-year follow-up

  • Adverse reactions

    start of treatment until 3.5-year follow-up

Other Outcomes (1)

  • Reduction rate of immune-related cytokines

    The baseline period，12th week±14 days and 168th week±14 days

Study Arms (2)

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.

Drug: Huaier Granule

Standard treatment

NO INTERVENTION

Subjects receive routine diagnosis and treatment without taking Huaier granules.

Interventions

Huaier GranuleDRUG

10g each time, three times a day

Also known as: Z20000109（NMPA Approval Number）
Huaier Granule+Standard treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410011, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Nantong First People's Hospital

Nantong, Jiangsu, 226006, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

The International Peace Maternity & Child Health Hospital of China welfare institute

Shanghai, Shanghai Municipality, 200030, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

The First Hospital of Jiaxin

Jiaxin, Zhejiang, 314000, China

Location

Lishui Municipal Central Hospital

Lishui, Zhejiang, 323020, China

Location

Taizhou Central Hospital

Taizhou, Zhejiang, 318001, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zhimin Shao, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, PhD

CONTACT

+8618017312288zhimingshao@yahoo.com

Liang Huang, PhD

CONTACT

+8618121299334fdhlyx@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2027

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(13)