Proton and Carbon Ion Therapy for Certain Types of Breast Cancer
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer After Breast Conserving Surgery
This study is testing if using proton and carbon ion therapy after surgery can help people with certain types of breast cancer feel better and lower their chances of the cancer coming back.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05692661 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of proton and carbon ion radiotherapy for patients with HER2 positive and triple negative breast cancer following breast conserving surgery. The study aims to assess the safety and efficacy of this combined radiation approach, particularly for cancers that are known to be resistant to standard radiation treatments. By escalating the doses of these advanced radiation therapies, the trial seeks to improve local control of the disease and reduce the risk of recurrence. Participants will be closely monitored for treatment responses and side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with histologically confirmed HER2 positive or triple negative invasive breast carcinoma who have undergone breast conserving surgery.
Not a fit: Patients with distant metastasis or those who have previously received thoracic radiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce local recurrence rates in patients with HER2 positive and triple negative breast cancer.
How similar studies have performed: While the use of proton and carbon ion therapies is gaining interest, this specific combination for HER2 positive and triple negative breast cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Shanghai Proton and Heavy Ion center — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.