A multicenter, double -blind, randomized, placebo-controlled study on stage II-III triple-negative breast cancer with lymph node metastasis treated by Huaier granules

A multicenter, double -blind, randomized, placebo-controlled study on stage III-III triple-negative breast cancer with lymph node metastasis treated by Huaier granules

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16007737

Enrollment

Unknown

Registered

2016-01-12

Start date

2016-01-15

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Experimental group:Huaier granules

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) aged 18-70 years; 2) pathologically diagnosed as invasive ductal breast cancer; 3) modified radical mastectomy (modified radical mastectomy SOP); 4) lymph node metastasis confirmed by postoperative pathology; 5) strage II-III; 6) molecular type: triple negative breast cancer( diagnosis criteria of triple negative breast cancer); 7) time from operation day to enrollment <6 months; 8) postoperative chemotherapy regime: (epirubicin / pirarubicin+ cyclophosphamide)*4 cycles (Paclitaxel or docetaxel)*4 cycles; 9) time from the last chemotherapy to enrollment: 14-21 days; 10) if necessary, radiotherapy is given as schedule (indication for b reast cancer radiotherapy); 12) hepatic and renal function:serum creatinine<=1.5ULN, ALT(AST) <=2.5ULN; 13) no case history of other malignant tumors; 14) ECOG score <=2 (attached document 1); 15) compliance to this study; 16) voluntary to participate, signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) females in pregnancy or lactation, or have birth plan in study period; 2) with complications of severe heart, liver, kidney and endocrine system disease, and the estimated survival< 2 years; 3) allergic to this drug or any constituent; 4) incomplete resection or with tumor residual under a microscope; 5) do not undergo radiotherapy according NCCN guideline; 6) receiving neoadjuvant therapy; 7) receiving different chemotherapy; 8) bilateral breast cancer; 9) with clinical or radiographic evidences of distant metastasis; 10) involved in other clinical trials in recent 3 months; 11) low compliance or other conditions unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
disease free survival;5-year overall survival;	—

Countries

China

Contacts

Public ContactJiang Jun

jcbd@medmail.com.cn+86 023-68765633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026