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NCT05692661
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer
Phase 1 trial testing proton plus carbon ion radiotherapy in Triple Negative Breast Cancer in 24 participants. Status unknown.
10 October 2025
Quick facts
| Lead sponsor | Shanghai Proton and Heavy Ion Center |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 10 January 2023 |
| Primary completion | 10 October 2025 |
| Estimated completion | 10 January 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- proton plus carbon ion radiotherapy
Conditions studied
- Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
- HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
Sponsor
Shanghai Proton and Heavy Ion Center — full company profile →
Who can join
Adults 18 to 80, female only, with Triple Negative Breast Cancer or HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant. Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A future directions of renal cell carcinoma treatment: combination of immune checkpoint inhibition and carbon ion radiotherapy.
Zheng Z, Yang T, Li Y, Qu P, et al · · 2024 · cited 9× · PMID 39091498 · DOI 10.3389/fimmu.2024.1428584
Verify or expand the search:
- PubMed search for NCT05692661
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Triple Negative Breast Cancer
Currently open trials in the same condition.
- NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H · Phase 3 · recruiting
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07281976 — A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer · Phase 1, PHASE2 · recruiting
- NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE) · NA · recruiting
Other Shanghai Proton and Heavy Ion Center trials
Trials by the same sponsor.
- NCT07135661 — Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy · NA · recruiting
- NCT05613452 — Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer · Phase 2 · recruiting
- NCT06677879 — A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer. · Phase 2 · recruiting
- NCT05878678 — Prospective Study of Particle Radiotherapy for Breast Cancer With Different Arm Position · Phase 2 · unknown
- NCT05692674 — A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Br · Phase 2 · 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 NCT05692661 (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 Shanghai Proton and Heavy Ion Center
- Last refreshed: 20 January 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/NCT05692661.
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