Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06954623

Partial Breast Re-irradiation for Breast Cancer

Led by University Hospital Heidelberg · Updated on 2026-03-10

20

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Partial Breast Re-irradiation for Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed recurrent or new invasive breast cancer or DCIS in the same breast after prior radiation
  • Indicated for re-irradiation following repeat breast-conserving surgery
  • Tumor size less than 3 cm
  • Clinically node-negative (no lymph node involvement)
  • Negative surgical resection margin (R0)
  • At least 12 months since prior radiation therapy to the ipsilateral breast
  • ECOG performance status of 0 to 2
  • Ability to understand the trial and provide written informed consent
  • Female and 18 years of age or older
Not Eligible

You will not qualify if you...

  • Presence of distant metastases
  • Receiving chemotherapy at the same time as study treatment (endocrine therapy allowed)
  • Not recovered from acute side effects of prior treatments
  • Diagnosis of another carcinoma within the last 5 years requiring immediate treatment (except certain skin and cervical cancers)
  • Pregnant or breastfeeding women
  • Participation in another competing clinical trial
  • History of active connective tissue diseases such as lupus or scleroderma
  • Medical implants incompatible with particle therapy at the treatment center

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Heidelberg, Department Radiation Oncology

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

E

Eva Meixner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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