Huaier Granule treatment for women with triple negative breast cancer

Huaier Granule in Treating Women With Triple Negative Breast Cancer

This study is testing whether a traditional Chinese medicine called Huaier Granule can help women with triple negative breast cancer live longer and stay cancer-free after surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shandong University (other)
• Locations: 1 site (Ji'nan, Shandong)
• Trial ID: NCT02615457 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Huaier Granule, a traditional Chinese medicine, in women with surgically removed triple negative breast cancer. Participants are randomized into two groups: one receiving Huaier Granule as adjuvant treatment and the other receiving a blank control. The study aims to compare disease-free survival and overall survival between the two groups over time. The trial is designed to provide insights into the potential benefits of Huaier Granule in improving outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 who have had triple negative breast cancer surgically removed and meet specific health criteria.

Not a fit: Patients with stage IV breast cancer or those whose triple negative breast cancer has not been surgically removed will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease-free and overall survival rates for women with triple negative breast cancer.

How similar studies have performed: Previous studies have shown promising results for Huaier in inhibiting breast cancer cells, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age: ≥ 18 and ≤ 75 years, female;
* Triple negative breast cancer has been surgically removed;
* The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
* Not receiving any preoperative anticancer drugs;
* The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
* Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \> 1.5×109/L;
* The expected survival time ≥ 6 months;
* The subjects volunteer to sign the informed consent.

Exclusion Criteria:

* Patients with stage IV breast cancer;
* Triple negative breast cancer was not surgically removed;
* Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
* Pregnant or lactating women;
* Those with active bleeding due to various reasons;
* Those with HIV infection or AIDS-associated diseases;
* Those with severe acute and chronic diseases;
* Those with severe diabetes;
* Those with serious infectious diseases;
* Those who can not take drugs by oral route;
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
* Conditions that are considered not suitable for this study investigators

Where this trial is running

Ji'nan, Shandong

• Qilu hospital of Shandong University — Ji'nan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Qifeng Yang, Professor

Conditions: Triple Negative Breast Cancer