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Huaier Granule for Stage II and III Triple Negative Breast Cancer with lymph node metastasis: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial

Huaier Granule for Stage II and III Triple Negative Breast Cancer with lymph node metastasis: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015390
Enrollment
Unknown
Registered
2018-03-28
Start date
2018-05-01
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Triple Negative Breast Cancer

Interventions

Sponsors

The First Afliliated Hospital of AMU (Southwest hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old; 2. The pathological diagnosis of breast invasive ductal carcinoma; 3. Complete the modified radical mastectomy; 4. Postoperative pathology confirmed with lymph node metastasis; 5. TNM Stage II-III; 6. Molecular classification of Triple Negative Breast Cancer; 7. Within 14-28days at the end of the time of surgery and chemotherapy; 8. According to the NCCN(2017.V3)guidelines for chemotherapy; 9. If need to radiotherapy, receive radiation therapy according to the plan; 10. No local recurrence and distant metastasis; 11. Liver and kidney functionScr=1.5ULNALT(AST) =2.5ULN; 12. No other history of malignancy; 13. Eastern Cooperative Oncology Group (ECOG) =2; 14. Have the ability to compliance protocol; 15. Volunteered for the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or plan a pregnancy during the study period; 2. With severe heart, liver, kidney, endocrine system disease patients, and the expected lifetime < 2 years; 3. Allergic to Huaier Granule or its composition; 4. Incomplete or have residual tumor resection surgery; 5. No according to radiation scheme; 6. Not according to NCCN guidelines for chemotherapy; 7. Bilateral breast cancer patients; 8. Clinical or radiographic indicates a distant metastases; 9. Participation in any other clinical trial within three months; 10. Poor compliance or have conditions that are considered not suitable for this study investigators.

Design outcomes

Primary

MeasureTime frame
disease-free survival;

Secondary

MeasureTime frame
5-year overall survivals;Karnofsky;EORTC QLQ-C30;

Countries

China

Contacts

Public ContactJiang Jun

The First Afliliated Hospital of AMU (Southwest hospital)

jcbd@medmail.com.cn+86 13508319495

Outcome results

None listed

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