Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07355361
Eligibility Criteria:
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:
* \*\*Exclusion Criteria\*\*
1. Known history of chronic kidney disease (eGFR \<60 ml/min/1.73m²) or diabetic nephropathy.
2. Proteinuria attributed to other diseases, including but not limited to primary renal disease, hypertension, urinary tract infection, systemic lupus erythematosus, or multiple myeloma.
3. Current use of ACEI/ARB medications (unless the dosage has been stable for ≥4 weeks prior to enrollment).
4. Known allergy, contraindication, or specific precaution to any component of Huaier Granule.
5. Women who are pregnant, breastfeeding, or planning to conceive.
6. Concurrent participation in any other clinical trial investigating medications for proteinuria.
7. Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07355361
Study Brief:
Protocol Section:
NCT07355361