Clinical trial NCT05871437: Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer
Official title: Clinical Study of Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Early-stage Breast Cancer
Keywords: Huaier granule
early-stage breast cancer
level of tumor markers
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
name: Huazhong University of Science and Technology
First posted: 2023-05-23
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single center, single-arm, phase IV study， to evaluate the effect of Huaier Granule on reducing the level of tumor markers in early-stage breast cancer patients.

Detailed description: This clinical trial is expected to include 379 patients in the follow-up stage after breast cancer surgery who visited the Breast Surgery Department of Fudan University Shanghai Cancer Hospital from October 2022 to October 2024. Excluding cases where tumor markers (CEA/CA125/CA153) exceed the normal upper limit level in the case of recurrence and metastasis. All participants received treatment with Huaier granules for 1 year, or experienced intolerable toxicity, withdrew from the study for any reason or died, whichever occurred first.

The main research indicator is the recovery rate of tumor markers (CEA/CA125/CA153) to normal.

Eligibility criteria: Inclusion Criteria:

* 18 ≤ age ≤ 75 years old, regardless of gender.
* Postoperative pathological diagnosis of breast cancer.
* Imaging or pathological examination without evidence of recurrence or metastasis.
* If tumor markers are elevated, it is necessary to go to the corresponding department for medical treatment or issue a corresponding examination when necessary to exclude recurrence, metastasis or the second primary tumor of breast cancer.
* One or more tumor markers in CEA/CA125/CA153 exceed the upper limit of normal values.
* 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.
* The patient's ECOG physical state score is 0 or 1.
* The subjects participated in this study voluntarily and signed an informed consent form.

Exclusion Criteria:

* Diagnosed as any other malignant tumor within the 5 years prior to enrollment, except for malignant tumors with low risk of metastasis and death (5-year survival rate\>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ.
* Imaging or pathological confirmation of recurrence and metastasis.
* Serious infections (CTCAE\>Level 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and 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, excluding the use of prophylactic antibiotics.
* Suffering from severe acute and chronic diseases.
* Suffering from severe diabetes whose blood sugar cannot be effectively controlled.
* Patients who are unable to take oral medication, those who are allergic to the ingredients of Huaier granules, and pregnant or lactating women.
* Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance.
* The researcher believes that it is not suitable to participate in this study.

Primary outcomes:
measure: Recovery rate of any tumor marker (CEA/CA125/CA153) to normal
timeFrame: Start of treatment until 2-year follow-up
Secondary outcomes:
measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE)
timeFrame: Start of treatment until 2-year follow-up
measure: The incidence and severity of adverse reaction (ADR), severe adverse reactions(SADR), suspicious and unexpected severe adverse reaction (SUSAR)
timeFrame: Start of treatment until 2-year follow-up
measure: The rate at which immune related cytokines （IL-1β，IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12，IL-17，TNF-α，IFN-α，IFN-γ）return to normal levels
timeFrame: The 3rd and 12th months after starting treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhimin Shao, PhD
role: PRINCIPAL_INVESTIGATOR
References: