Partial proton re-irradiation of the breast after a recurrence
Partial Breast Re-irradiation for Breast Cancer Recurrences After Repeat Breast-conserving Surgery With Proton Beam Therapy
This trial tests partial-breast proton re-irradiation for adults with a recurrent or new ipsilateral breast cancer after prior whole-breast radiation who have had repeat breast-conserving surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT06954623 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm phase II study treating up to 20 patients with partial-breast proton beam re-irradiation after repeat breast-conserving surgery for ipsilateral recurrent or new primary breast cancer. Eligible patients are node-negative with tumors under 3 cm, negative margins, ECOG ≤2, and at least 12 months since prior breast irradiation. The protocol uses the dosimetric advantages of the proton Bragg Peak to limit dose to nearby organs-at-risk while delivering therapeutic dose to the tumor bed. Safety, acute and late toxicity, and local control will be followed to characterize feasibility of this re-irradiation approach.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed ipsilateral recurrent or new primary invasive breast cancer or DCIS after prior breast irradiation who underwent repeat breast-conserving surgery, with tumor ≤3 cm, clinically node-negative, negative resection margins, ECOG ≤2, and at least 12 months since prior RT.
Not a fit: Patients with distant metastases, clinically positive nodes, tumor >3 cm, positive margins, those requiring concurrent chemotherapy, or those who are medically unfit or too recently irradiated are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve local control of breast recurrences while lowering radiation dose to surrounding organs and reducing treatment-related toxicity.
How similar studies have performed: Prospective experience with ipsilateral breast re-irradiation is limited and proton re-irradiation is relatively novel, with only small series and dosimetric reports suggesting reduced normal-tissue dose but limited long-term outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed recurrent (or new primary) ipsilateral invasive breast cancer or DCIS after prior RT of the ipsilateral breast * indication for re-irradiation after repeat breast conserving surgery (e.g. lumpectomy, wide excision, …) * tumor size \< 3 cm * clinically node-negative (cN0) * negative resection margin (R0) * time interval: start of re-RT to prior RT ≥ 12 months * ECOG Performance status ≤ 2 * ability of subject to understand character and individual consequences of the clinical trial * written informed consent * ≥18 years of age Exclusion Criteria: * distant metastases * concomitant chemotherapy (concomitant endocrine hormonal therapy is allowed; sequential chemotherapy is allowed) * patients who have not recovered from acute toxicities of prior therapies * known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy * pregnant or lactating women * participation in another competing clinical study or observation period of competing trials * history of active connective tissue disorder (i.e. systemic lupus erythematosus, scleroderma, dermatomyositis, xeroderma pigmentosum, …) * medical implants, which are at the time of reirradiation not eligible for particle therapy at Heidelberg Ion Beam Therapy Center
Where this trial is running
Heidelberg
- University Hospital Heidelberg, Department Radiation Oncology — Heidelberg, Germany (Recruiting)
Study contacts
- Principal investigator: Juergen Debus, MD — University Hospital Heidelberg
- Study coordinator: Eva Meixner, MD
- Email: eva.meixner@med.uni-heidelberg.de
- Phone: 0049 6221 56 8201
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.