Huaier Granule and Proteinuria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Huaier Granule, Antitumor therapy, Proteinuria Management.
- Who it may be relevant to
- Registry conditions: Proteinuria, Breast Cancer Patients. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter, Randomized, Parallel-Controlled Clinical Trial on Huaier Granule for Proteinuria Associated With Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients
Overview
The goal of this clinical trial is to learn if adding Huaier Granule to standard care can treat proteinuria (excess protein in the urine) in adult female breast cancer patients (aged 18-75) who developed this condition as a side effect of their immunotherapy or anti-angiogenic cancer treatment. The main question it aims to answer is: \* Does the addition of Huaier Granule to standard care improve the effectiveness of proteinuria treatment after 8 weeks? Researchers will compare the group receiving standard care plus Huaier Granule to the group receiving standard care alone to see if the combination is more effective at reducing protein levels in the urine. Participants will: * Be randomly assigned to one of the two study groups. * Continue their prescribed anti-cancer therapy (immunotherapy or anti-angiogenic therapy). * Receive standard medical care for proteinuria from a kidney specialist. * If in the experimental group, take Huaier Granule orally, three times a day. * Attend clinic visits every 4 weeks for up to 24 weeks for check-ups and tests, including urine and blood tests.
Interventions
- Drug Huaier Granule
Huaier Granule Group: Participants will take Huaier Granule (Z20000109) on top of their standard treatment. The dosing is 10g, orally, three times a day. Treatment continues until the study ends, or an event such as disease progression, unacceptable side effects, withdrawal, or death occurs, whichever comes first. The investigator can also stop treatment if it's no longer deemed beneficial. Refer to the drug label for details. The investigator will decide on continued use if the background cance - Drug Antitumor therapy
The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine. - Drug Proteinuria Management
Specialist-managed care (including follow-up or drug therapy \[excluding Huaier Granule\]) initiated post-proteinuria diagnosis.
Primary outcome measures
- Response rate of proteinuria treatment at Week 8 [Time frame: From enrollment to the end of treatment at 8 weeks.]
Secondary outcome measures (4)
- Response rate of proteinuria treatment at Week 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
- Change from baseline in 24-hour urinary protein quantification at Weeks 8 and 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
- Mean percent reduction in 24-hour urinary protein quantification at Weeks 8 and 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
- Other Renal Adverse Events at Weeks 8 and 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
Eligibility criteria
Inclusion criteria
- \*\*Inclusion Criteria\*\*
- Female patients aged 18-75 years.
- Histopathologically confirmed diagnosis of breast cancer.
- Currently receiving or having a prior history of immunotherapy and/or anti-angiogenic therapy.
- First-time detection of proteinuria on urinalysis, graded as +, ++, or +++.
- 24-hour urinary protein quantification between 0.15g and 3.5g (exclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Karnofsky Performance Status (KPS) score ≥70.
- No prior treatment with Huaier Granule within one month before enrollment.
- Life expectancy of at least 6 months.
- Willingness to voluntarily participate in the study and provision of signed informed consent.
Exclusion criteria
- \*\*Exclusion Criteria\*\*
- Known history of chronic kidney disease (eGFR <60 ml/min/1.73m²) or diabetic nephropathy.
- Proteinuria attributed to other diseases, including but not limited to primary renal disease, hypertension, urinary tract infection, systemic lupus erythematosus, or multiple myeloma.
- Current use of ACEI/ARB medications (unless the dosage has been stable for ≥4 weeks prior to enrollment).
- Known allergy, contraindication, or specific precaution to any component of Huaier Granule.
- Women who are pregnant, breastfeeding, or planning to conceive.
- Concurrent participation in any other clinical trial investigating medications for proteinuria.
- Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07355361 · SCHBCC-N093