Using Huaier Granule with chemotherapy for advanced breast cancer treatment
Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
This study is testing if adding Huaier Granule to standard chemotherapy helps women with locally advanced breast cancer respond better to treatment before surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shandong University Academic / other |
| Drugs / interventions | chemotherapy, Cyclophosphamide |
| Locations | 1 site (Ji'nan, Shandong) |
| Trial ID | NCT02627248 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Huaier Granule combined with standard neoadjuvant chemotherapy agents, including Epirubicin, Cyclophosphamide, and Docetaxel, in treating women with locally advanced breast cancer. The study aims to determine if the addition of Huaier enhances the treatment's efficacy compared to chemotherapy alone. Participants will receive treatment before surgery to assess the tumor's response. The trial focuses on patients with specific types of breast cancer that are operable and meet certain health criteria.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with locally advanced breast cancer that is operable and meets specific health criteria.
Not a fit: Patients with rare histological types of breast cancer or noninvasive cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for women with locally advanced breast cancer by enhancing the effectiveness of chemotherapy.
How similar studies have performed: While the use of Huaier in combination with chemotherapy is a novel approach, previous studies have suggested potential synergistic effects in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria: * Age: ≥ 18, female; * Breast cancer (TNM II, III, IV) larger than 2cm in maximal diameter able to benefit from neoadjuvant chemotherapy; * Ductal or lobular histological type of the breast tumor; * The diagnosis and breast cancer has been confirmed by pathological examination; * 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 ≥ 8 months; * The subjects volunteer to sign the informed consent. * Exclusion Criteria: * Breast cancers of rare histological type (other than ductal and lobular); * Noninvasive cancer; * Presence of organ, bone, or skin metastases; * 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.