NCT02627248

Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators have found that Huaier could exert synergistic effects with Epirubicin, Cyclophosphamide, and Paclitaxel on breast cancer cells. It is not yet known whether combination chemotherapy is more effective when given together with Huaier in the neoadjuvant setting . PURPOSE: To evaluate the effects of treatment with Huaier Granule in managing locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Huaier Granule	20g tid, orally
DRUG	Epirubicin	70 mg/m² ivdrip, d1 for both TEC and ET regimes
DRUG	Docetaxel	75 mg/m² ivdrip, d2 for both TEC and ET regimes
DRUG	Cyclophosphamide	600 mg/m² ivdrip, d2 for TEC regimes

Timeline

• Start date: 2015-10-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2015-12-10
• Last updated: 2015-12-10

Locations

1 site across 1 country: China