No phaseActive, not recruiting
Partial Breast Re-irradiation for Breast Cancer (BREAST)
Partial Breast Re-irradiation for Breast Cancer Recurrences After Repeat Breast-conserving Surgery With Proton Beam Therapy
- Sponsor
- University Hospital Heidelberg (Academic or other)
- Enrolment
- 20 planned
- Conditions
- Breast Cancers
- Interventions
- Radiation Therapy
- Ages
- adults, older adults
- Registry
- NCT06954623
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- skin toxicity
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered