Clinical trial · Interventional
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer After Breast Conserving Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| proton plus carbon ion radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- proton plus carbon ion radiotherapy
- description
- CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels.
- interventionNames
- Radiation: proton plus carbon ion radiotherapy
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 3 months after the completion of CIRT
- description
- Treatment related acute toxicity assessed by CTCAE v4.03
Secondary outcomes (3)
- measure
- Local regional recurrence
- timeFrame
- within 5 years after radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry \[IHC\] 3+ and or fluorescence in situ hybridization \[FISH\] amplified; Triple Negative: estrogen receptor \[ER\] and progesterone receptor \[PR\] \< 1%, HER2 negative \[IHC 1+ or 2+ FISH non-amplified\]) * Age ≥ 18 years and ≤ 80 years. * The primary tumor must be excised via breast conserving surgery. * Stage p T1-2 N0 M0 * ECOG performance status ≤2. Exclusion Criteria: * Invasive breast cancer not confirmed by pathology. * Distant metastasis * Prior thoracic radiation. * Pregnancy or lactating.
References
Publications (0)
Data not yet available