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

Official title

A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

Overview

This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.

Detailed description

This study used a blank control design and included at least 384 subjects. The experimental group and control group were randomized in a 2:1 ratio (at least 256 subjects in the experimental group and at least 128 subjects in the control group). Patients in the experimental group were treated with Huaier Granules (10g/dose, 3 times/day), while undergoing routine diagnosis and treatment; The control group received routine diagnosis and treatment, but did not take Huaier granules until the subjects experienced disease progression or intolerance.

Interventions

• Drug Huaier Granule
  10g each time, three times a day

Primary outcome measures

• Investigator evaluated progression free survival [Time frame: start of treatment until 3.5-year follow-up]

Secondary outcome measures (4)

• Overall survival(OS) [Time frame: start of treatment until 3.5-year follow-up]
• Clinical benefit rate (CBR) [Time frame: start of treatment until 3.5-year follow-up]
• Objective response rate (ORR) [Time frame: start of treatment until 3.5-year follow-up]
• Adverse reactions [Time frame: start of treatment until 3.5-year follow-up]

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.

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 · 13 centers

• The Fourth Hospital of Hebei Medical University — Shijiazhuang
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• The First Hospital of Hunan University of Chinese Medicine — Changsha
• The Third Xiangya Hospital of Central South University — Changsha
• Nantong First People's Hospital — Nantong
• Northern Jiangsu People's Hospital — Yangzhou
• The International Peace Maternity & Child Health Hospital of China welfare institute — Shanghai
• Fudan University Shanghai Cancer Center — Shanghai
• … and 5 more centers

Identifiers

NCT: NCT05860907 · HE-202210-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗