Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
NCT02627248 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2015-12-10
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
Interventions
- DRUG
-
Huaier Granule
20g tid, orally
- DRUG
-
Epirubicin
70 mg/m² ivdrip, d1 for both TEC and ET regimes
- DRUG
-
75 mg/m² ivdrip, d2 for both TEC and ET regimes
- DRUG
-
600 mg/m² ivdrip, d2 for TEC regimes
Sponsors & Collaborators
-
Shandong University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2025-10-31
- Completion
- 2025-10-31
Countries
- China
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