Intraoperative electron radiotherapy for early breast cancer
Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer
This study is testing if giving targeted radiation during surgery can help people with low-risk early breast cancer feel better and recover faster than the usual whole breast radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT03838419 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of intraoperative electron radiotherapy as an alternative to standard whole breast irradiation for patients with low-risk early breast cancer. The goal is to reduce the treatment time and minimize side effects, particularly fatigue, which can significantly impact the quality of life for patients undergoing traditional radiotherapy. Participants will receive targeted radiation during their surgery, potentially leading to improved outcomes and reduced recovery times. The study aims to evaluate the effectiveness and safety of this approach compared to conventional methods.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with histologically confirmed invasive breast cancer, total tumor size less than 2.5 cm, and specific receptor status.
Not a fit: Patients with aggressive tumor characteristics, extensive microcalcifications, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment duration and side effects for patients with early-stage breast cancer.
How similar studies have performed: Other studies have shown promise with intraoperative radiotherapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Heidelberg
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.