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NCT05871437
Prospective, Multicenter, Randomized Controlled Clinical Trial on the Effect of Huaier Granules in Reducing Tumor Marker Levels in Patients With Early-Stage Breast Cancer
Phase 4 trial testing Huaier granule in Breast Cancer in 232 participants. Not yet recruiting.
1 January 2026
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 232 |
| Start date | 1 September 2025 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Huaier granule — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Recovery rate of any tumor marker (CEA/CA125/CA153) to normal
Time frame: Start of treatment until 2-year follow-up
The rate at which one or more tumor markers (CEA/CA125/CA153) exceed the upper limit of normal values before patient enrollment and any tumor marker that rises before enrollment decreases to the normal range after the end of Huaier Granule treatment
Sponsor's own description
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the rate of reduction of tumor markers to normal levels in breast cancer patients treated with Huaier granules compared to the control group.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05871437
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Huaier granule
Trials testing the same drug.
- NCT05498766 — Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients · Phase 4 · not yet recruiting
- NCT05839314 — Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy · Phase 4 · recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05871437 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 1 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05871437.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing