Comparing whole breast and partial breast radiation for early breast cancer
Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
This study is testing whether whole breast radiation or partial breast radiation works better and has fewer side effects for women with early breast cancer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Oncology Institute of Vojvodina Government |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Novi Sad, Vojvodina) |
| Trial ID | NCT05914831 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves female patients with early breast cancer who have undergone surgical treatment. Participants are randomized into two groups: one receiving whole-breast irradiation using an ultra-hypofractionated regimen, and the other receiving partial breast irradiation, both at a total dose of 26 Gy in 5 fractions. The study aims to compare the effectiveness and adverse effects of these two radiotherapy protocols in terms of disease control and patient survival. Additionally, it seeks to explore correlations between various parameters and the efficacy and toxicity of the treatments.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with invasive ductal carcinoma who have undergone breast-conserving surgery and meet specific tumor and lymph node criteria.
Not a fit: Patients with triple-negative breast cancer or those who have received neoadjuvant systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved radiotherapy protocols that minimize side effects while maintaining effective cancer control.
How similar studies have performed: Other studies have explored similar approaches in breast radiotherapy, but the specific ultra-hypofractionated comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Breast-conserving surgery * Invasive ductal carcinoma * Age ≥ 50 * Tumor size ≤ 3 cm * R0 resection * Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm * pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi * Hormone receptor status - any * Histological grade G1 or G2 Exclusion Criteria: * Neoadjuvant systemic therapy * TNBC (triple-negative breast cancer) * Extensive intraductal component (EIC) * Lymphovascular invasion (LVI) * associated DCIS \> 2.5 cm in size or high nuclear grade
Where this trial is running
Novi Sad, Vojvodina
- Oncology Institute of Vojvodina — Novi Sad, Vojvodina, Serbia (Recruiting)
Study contacts
- Study coordinator: Olivera Ivanov
- Email: ivanov.olivera@onk.ns.ac.rs
- Phone: 0214805496
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.