Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer

This is a prospective, multicenter, randomized, parallel controlled, open-label study. The primary purpose of this study is to evaluate the efficacy of Huaier Granule on postoperative adjuvant therapy of high-risk early-stage triple-negative invasive ductal carcinoma. The Secondary purposes are to evaluate the safety of long-term use of Huaier granules as postoperative adjuvant treatment of high-risk early-stage triple-negative invasive ductal carcinoma, and the changes of quality of life score after treatment with Huaier granule.

Trial Details

NCT ID
NCT04790305
Phase
PHASE4
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Huaier Granule
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Hefei, Anhui, China|31.86389,117.28083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Fuzhou, Fujian, China|26.06139,119.30611

Key Eligibility Criteria

  • Aged from 18 to 70.
  • Histologically confirmed as breast invasive ductal carcinoma.
  • Molecular typing of breast lesions is triple-negative breast cancer, when the patient had multicentric lesions at the same time, all invasive lesio…
  • Regional lymph node metastasis confirmed by postoperative pathology \[except isolated tumor cells ( ITC )\], or tumor response did not achieve path…

For full eligibility, visit ClinicalTrials.gov.

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