Breast Cancer Patients, Proteinuria
Conditions
Keywords
proteinuria, Immunotherapy, Anti-angiogenic therapy, Breast cancer patients
Brief summary
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
DRUGHuaier 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 cancer therapy is changed due to progression.
The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.
DRUGProteinuria Management
Specialist-managed care (including follow-up or drug therapy \[excluding Huaier Granule\]) initiated post-proteinuria diagnosis.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* \*\*Inclusion Criteria\*\* 1. Female patients aged 18-75 years. 2. Histopathologically confirmed diagnosis of breast cancer. 3. Currently receiving or having a prior history of immunotherapy and/or anti-angiogenic therapy. 4. First-time detection of proteinuria on urinalysis, graded as +, ++, or +++. 5. 24-hour urinary protein quantification between 0.15g and 3.5g (exclusive). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Karnofsky Performance Status (KPS) score ≥70. 8. No prior treatment with Huaier Granule within one month before enrollment. 9. Life expectancy of at least 6 months. 10. Willingness to voluntarily participate in the study and provision of signed informed consent.
Exclusion criteria
* \*\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of proteinuria treatment at Week 8 | From enrollment to the end of treatment at 8 weeks. | The proportion of subjects (across both groups) achieving a best overall response of Complete Response, Partial Response, or Stable Disease in proteinuria at 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of proteinuria treatment at Week 16 | From enrollment to the end of treatment at 16 weeks | Response rate at Week 16 (defined as the proportion of subjects with complete response, partial response, or stable disease in proteinuria) |
| Change from baseline in 24-hour urinary protein quantification at Weeks 8 and 16 | From enrollment to the end of treatment at 16 weeks | The between-group difference in the mean change from baseline in 24-hour urinary protein quantification at Week 8. |
| Mean percent reduction in 24-hour urinary protein quantification at Weeks 8 and 16 | From enrollment to the end of treatment at 16 weeks | The mean of the percentage change, which is calculated for each subject as: (Baseline 24-hour urinary protein value - Week 8 value) / Baseline value × 100%, averaged across all subjects in both the experimental and control groups. |
| Other Renal Adverse Events at Weeks 8 and 16 | From enrollment to the end of treatment at 16 weeks | The incidence and severity of other renal adverse events (including but not limited to elevated blood pressure, increased serum creatinine, elevated blood urea nitrogen, acute kidney injury, nephritis, nephrotic syndrome, and renal failure) are defined as follows: Incidence is defined as the proportion of subjects experiencing any of the specified other renal adverse events within the respective total population. Severity will be graded according to the criteria described in the section for definitions and assessment of adverse events. |
Countries
China
Contacts
CONTACTZhi-Ming Shao, MD, PhD
CONTACTPeng Ji, Dr.
PRINCIPAL_INVESTIGATORZhi-Ming Shao
Fudan University
Outcome results
None listed