Last reviewed · How we verify
NCT05981014
Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
Phase 1, PHASE2 trial testing Sentinel Lymph Node Biopsy (SLNB) in Breast Neoplasms in 196 participants. Currently enrolling.
31 December 2030
Quick facts
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 196 |
| Start date | 1 August 2023 |
| Primary completion | 31 December 2030 |
| Estimated completion | 31 May 2035 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sentinel Lymph Node Biopsy (SLNB)
- Doxorubicin
- Epirubicin (EPIRUBICIN) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Tumor-draining lymph node-derived lymphocyte (LNL) — full drug profile →
- Interleukin-2
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Who can join
Adults 18 to 70, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
RATIONALE: Patients with HER2-negative breast cancer not responding to initial neoadjuvant chemotherapy might have lower chances for a pathologic complete response (pCR) at definitive surgery, indicating worse prognosis. Adoptive cell therapy has demonstrated efficacy in advanced breast cancer, but whether the addition of adoptive cell therapy to neoadjuvant chemotherapy could increase the pCR rate remains unclear. Tumor-draining lymph node-derived lymphocytes (LNLs) that have abundant tumor-reactive T cells, but not exhausted T cells, are easy to produce. It is not yet known whether LNL treatment is safe and effective in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy. PURPOSE: This open-label phase I/II trial is to investigate the safety and efficacy of autologous LNL in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Lymphatic system regulation of anti-cancer immunity and metastasis.
Lei PJ, Fraser C, Jones D, Ubellacker JM, et al · · 2024 · cited 13× · PMID 39211044 · DOI 10.3389/fimmu.2024.1449291
Verify or expand the search:
- PubMed search for NCT05981014
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sentinel Lymph Node Biopsy (SLNB)
Trials testing the same drug.
- NCT06121570 — Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breas · Phase 1 · recruiting
- NCT03255577 — Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer · NA · active not recruiting
Other recruiting trials for Breast Neoplasms
Currently open trials in the same condition.
- NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
- NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
- NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
- NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
- NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · recruiting
Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials
Trials by the same sponsor.
- NCT07168083 — Efficacy and Safety of Sacituzumab in Patients With OCCC After Immunotherapy Progression · not yet recruiting
- NCT07413497 — A Prospective Observational Clinical Study on Exploring the Value of Surgical Excision Combined With 32P Application in · not yet recruiting
- NCT07461077 — Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer · NA · not yet recruiting
- NCT07533526 — Effects of Instrument-Assisted Constant-Speed Injection Versus Manual Injection on Pain From Large-Volume Subcutaneous I · NA · not yet recruiting
- NCT07408648 — A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological · 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 NCT05981014 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Last refreshed: 8 August 2023
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/NCT05981014.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing