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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Group | Active Comparator | Antitumor therapy + Proteinuria management + Huaier Granule treatment |
|
| B Group | Active Comparator | Proteinuria management + Huaier Granule treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaier Granule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of proteinuria treatment at Week 8 | 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. | From enrollment to the end of treatment at 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of proteinuria treatment at Week 16 | Response rate at Week 16 (defined as the proportion of subjects with complete response, partial response, or stable disease in proteinuria) | From enrollment to the end of treatment at 16 weeks |
| Change from baseline in 24-hour urinary protein quantification at Weeks 8 and 16 |
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Inclusion Criteria:
**Inclusion Criteria**
Exclusion Criteria:
**Exclusion Criteria**
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-Ming Shao, MD, PhD | Contact | +86-021-64175590 | zhi_ming_shao@163.com | |
| Peng Ji, Dr. | Contact | JIPENG_1010@163.COM |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Ming Shao | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Antitumor therapy | Drug | The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine. |
|
| Proteinuria Management | Drug | Specialist-managed care (including follow-up or drug therapy [excluding Huaier Granule]) initiated post-proteinuria diagnosis. |
|
The between-group difference in the mean change from baseline in 24-hour urinary protein quantification at Week 8. |
| From enrollment to the end of treatment at 16 weeks |
| Mean percent reduction in 24-hour urinary protein quantification at Weeks 8 and 16 | 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. | From enrollment to the end of treatment at 16 weeks |
| Other Renal Adverse Events at Weeks 8 and 16 | 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. | From enrollment to the end of treatment at 16 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |