Status:
RECRUITING
Partial Breast Re-irradiation for Breast Cancer
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Breast Cancers
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 pri...
Detailed Description
The therapeutic challenge in re-irradiation involves finding a balance between tumor control and the risk of severe toxicity from cumulative radiation doses in previously irradiated organs. Re-RT opti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06954623
Start Date
August 28 2025
End Date
September 1 2029
Last Update
September 2 2025
Active Locations (1)
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1
University Hospital Heidelberg, Department Radiation Oncology
Heidelberg, Germany, 69120