Preoperative partial breast irradiation for early-stage breast cancer
Impact of Preoperative Stereotactic Partial Breast Irradiation on Treatment Response, Treatment-related Toxicity, and Cosmetic Outcomes in Early-stage Breast Cancer: A Prospective, Phase II Clinical Trial
This study is testing if giving radiation therapy before surgery for early-stage breast cancer can lead to fewer side effects compared to the usual treatment given after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06677944 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the safety and effectiveness of preoperative partial breast irradiation (PBI) in patients with early-stage breast cancer. The study aims to determine if preoperative PBI results in fewer radiotherapy-related side effects compared to the standard postoperative PBI. A total of 47 patients will be enrolled, and their treatment outcomes, complications, quality of life, breast aesthetics, and fibrosis will be monitored over a one-year follow-up period. Evaluations will include assessments of acute and late complications as well as patient-reported quality of life questionnaires.
Who should consider this trial
Good fit: Ideal candidates are women aged 45 and older with histologically confirmed ductal carcinoma in situ or invasive breast cancer, with tumors sized 2.5 cm or smaller.
Not a fit: Patients with lymph node involvement, previous breast cancer treatment, or certain tumor characteristics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce side effects and improve the quality of life for patients undergoing treatment for early-stage breast cancer.
How similar studies have performed: Previous studies have shown success with hypofractionated radiotherapy approaches, suggesting potential for this novel preoperative method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast cancer. * Age ≥ 45 * cT1/cN0, tumor size ≤ 2.5cm * ECOG 0\~2 -ER+, HER2- Exclusion Criteria: * cN+ * Tumor located too close to the skin or chest wall (within 5 mm) * With previous treatment history for breast cancer * Neoadjuvant chemotherapy * Multicentric disease * Diffuse microcalcification * BRCA mutation * Paget's disease * In cases where tumor delineation is not achievable on CT/MRI images
Where this trial is running
Seoul
- Department of Radiation Oncology, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Yong Bae Kim — Department of Radiation Oncology, Yonsei University College of Medicine
- Study coordinator: Yong Bae Kim
- Email: ybkim3@yuhs.ac
- Phone: 82-2-2228-8106
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.