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NCT05692661

A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer

Status unknown Phase 1 Last updated 20 January 2023
What this trial tests

Phase 1 trial testing proton plus carbon ion radiotherapy in Triple Negative Breast Cancer in 24 participants. Status unknown.

Timeline
10 January 2023
Primary endpoint
10 October 2025
10 January 2026

Quick facts

Lead sponsorShanghai Proton and Heavy Ion Center
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment24
Start date10 January 2023
Primary completion10 October 2025
Estimated completion10 January 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other recruiting trials for Triple Negative Breast Cancer

Currently open trials in the same condition.

Other Shanghai Proton and Heavy Ion Center trials

Trials by the same sponsor.

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