Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

Launched by FUDAN UNIVERSITY · May 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Huaier Granules for patients with advanced breast cancer that hasn't spread to vital organs. The goal is to see how effective and safe this treatment is for those who have already tried other therapies without success. The trial will include adults aged 18 to 75 who have specific types of breast cancer and measurable tumors. Participants must also be in good enough health, with expected survival of at least 12 weeks, and must agree to join the study by signing a consent form.

If you or a loved one is considering participating, you should know that the trial is not yet recruiting participants. Eligible individuals will be monitored closely during the study to track how the treatment affects their condition. It’s important to note that there are certain criteria that would exclude someone from joining, such as having other serious health issues or being pregnant. This trial aims to find new options for those facing advanced breast cancer, providing hope for improved treatment outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 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.
• Exclusion Criteria:
• • 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.