NCT06954623 Partial Breast Re-irradiation for Breast Cancer
| NCT ID | NCT06954623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Breast Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-08-28 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer is the most common malignancy in women. Breast-conserving surgery (BCS) with adjuvant whole-breast irradiation (WBI) is currently the standard of care in the oncological treatment of primary breast cancer and offers an equivalent alternative to mastectomy. The primary aim of adjuvant radiotherapy (RT) is to improve local control and thus improve overall survival and breast cancer-specific mortality. However, nodal-negative women have a 10-year risk for local recurrences after RT in up to 15.6%. The management of ipsilateral breast cancer recurrence depends on the extent of tumor disease and staging results at the time of recurrence and mastectomy is currently the standard of care for previously irradiated patients. The application of particle therapy using proton beam therapy (PBT) represents an innovative radiotherapeutic technique for breast cancer patients. This trial will be conducted as a prospective single-arm phase II study in 20 patients with histologically proven invasive breast cancer recurrences with negative margins after repeat BCS and with an indication for local re-irradiation. Required time interval will be 1 year after previous RT to the ipsilateral breast. Patients will receive partial breast re-RT with proton beam therapy in 15 once daily fractions up to a total dose of 40.05 GyRBE. The primary endpoint is defined as the cumulative overall occurrence of acute / subacute skin toxicity grade ≥3 within 6 months after the start of re-RT.
Eligibility 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
Contact & Investigator
Juergen Debus, MD
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg
Frequently Asked Questions
Who can join the NCT06954623 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06954623 currently recruiting?
Yes, NCT06954623 is actively recruiting participants. Contact the research team at eva.meixner@med.uni-heidelberg.de for enrollment information.
Where is the NCT06954623 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT06954623 clinical trial?
NCT06954623 is sponsored by University Hospital Heidelberg. The principal investigator is Juergen Debus, MD at University Hospital Heidelberg. The trial plans to enroll 20 participants.
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