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NCT06121570
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
Phase 1 trial testing Sentinel Lymph Node Biopsy (SLNB) in Breast Neoplasms in 24 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 November 2023 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2031 |
| 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 phase I trial is mainly to investigate the safety of autologous LNL in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234 -
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 NCT06121570
- 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.
- NCT05981014 — Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer · Phase 1, PHASE2 · 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.
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Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials
Trials by the same sponsor.
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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 NCT06121570 (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 November 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/NCT06121570.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing