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

No results posted yet for this study

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

Docetaxel

75 mg/m² ivdrip, d2 for both TEC and ET regimes

DRUG

Cyclophosphamide

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627248 on ClinicalTrials.gov