Status:
RECRUITING
Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
Breast cancer is the most frequent malignancy in women. Standard therapy for early-stage breast cancer is breast conserving surgery (BCS) followed by adjuvant whole breast irradiation (WBI), which usu...
Eligibility Criteria
Inclusion
- Histologically confirmed invasive breast cancer
- Total tumor size \< 2.5 cm
- cN0
- estrogen receptor positive, HER2-receptor negative on immunohistochemistry
- age \>= 50 years
- ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion
- G3
- Extensive microcalcifications
- Invasive lobular carcinoma
- Clinically involved lymph nodes
- No invasive axillary lymph node staging planned
- Patients with significant mental or physical comorbidities that preclude regular follow-up
- Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
- previous radiotherapy of the breast
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT03838419
Start Date
October 1 2019
End Date
May 1 2030
Last Update
January 5 2024
Active Locations (1)
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1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120