Huaier granule treatment for early-stage breast cancer patients

Clinical Study of Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer

This study is testing if Huaier granules can help early-stage breast cancer patients lower their tumor marker levels after surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 379 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05871437 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Huaier granule in reducing tumor marker levels in patients with early-stage breast cancer following surgery. It is a prospective, single-center, single-arm phase IV study involving 379 patients at Fudan University Shanghai Cancer Hospital from October 2022 to October 2024. Participants will receive Huaier granules for one year, with the primary outcome being the recovery rate of tumor markers (CEA/CA125/CA153) to normal levels. Patients with elevated tumor markers will be monitored to exclude recurrence or metastasis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a postoperative diagnosis of early-stage breast cancer and elevated tumor markers.

Not a fit: Patients with evidence of recurrence or metastasis, or those whose tumor markers are not elevated, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help lower tumor marker levels in early-stage breast cancer patients, potentially improving their prognosis.

How similar studies have performed: While the specific use of Huaier granule is novel, similar studies targeting tumor markers in breast cancer have shown promising results.

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.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Zhimin Shao, PhD — Fudan University
• Study coordinator: Zhimin Shao, PhD

Conditions Early-stage Breast Cancer; Huaier granule; early-stage breast cancer; level of tumor markers