Table 3 Summary of the clinical trial regarding pre-operative partial breast irradiation
Trial ID, status | Title | Treatment | Primary endpoints | Secondary endpoints | Estimated primary completion date |
|---|---|---|---|---|---|
NCT05350722, recruiting | Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients (ABLATIVE-2) | Pre-operative single-dose radiotherapy (20 Gy) and BCS after 12 months | Pathologic complete response | Radiologic complete response, treatment-related adverse events, quality of life, cosmetic outcome, oncological outcomes, immune response and biomarkers | March 2025 |
NCT02913729, recruiting | Pre- Versus Postoperative Accelerated Partial Breast Irradiation (PAPBI-2) | Pre vs. post-operative PBI (5 × 5.2 Gy) and BCS 6 months after PBI | Cosmetic outcome | Pathologic complete response, postoperative complications | December 2022 |
NCT03917498, active/not recruiting | Single Pre-Operative Radiation Therapy—With Delayed Surgery for Low Risk Breast Cancer (SPORT-DS) | Pre-operative single-dose radiotherapy and BCS after 3 monthsa | Pathologic complete response | Radiation toxicity | February 28, 2020 (actual) |
NCT02212860, active/not recruiting | Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy (SIGNAL 2) | Pre-operative PBI (21 Gy or 3 × 10 Gy) and BCS after 14–20 days | Immune priming, angiogenesis, proliferation/hypoxia/apoptosis/invasion markers, toxicity | Cosmetic outcome, survival | April 2021 (actual) |
NCT03520894, recruiting | Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer (ROCK) | Pre-operative single-dose radiotherapy (21 Gy) and BCS after 30 days | Acute skin toxicity | Pathologic complete response, rate of complete resection, oncological outcomes, chronic toxicity, differential genetic expression, immune response and biomarkers | May 1, 2022 |
NCT04679454, recruiting | Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer (CRYSTAL) | Pre-operative single dose radiotherapy (18 Gy, 21 Gy, 24 Gy) and BCS after 4–8 weeks | Dose escalation, pathologic complete response | Chronic toxicity, cosmetic outcome, postoperative complications, oncological outcomes | March 2026 |
NCT03909282, recruiting | Phase 2 Surgical Excision vs Neoadjuvant Radiotherapy + Delayed Surgical Excision of Ductal Carcinoma (NORDIS) | Pre-operative PBI (5 × 6 Gy) and BCS after 3 months vs. upfront surgery | Rate of DCIS pathologic complete response | Wound complication, correlation of imaging characteristics and pathologic findings, rate of invasive carcinoma | September 2024 |
NCT04040569, recruiting | A Phase I Dose Escalation Study of Single Fraction Pre-operative Stereotactic Partial Breast Irradiation (S-PBI) for Early Stage Breast Cancer | Pre-operative single dose radiotherapy (30 Gy, 34 Gy, 38 Gy) and BCSb | Dose escalation, cosmetic outcome | - | September 2024 |
NCT02482376, active/not recruiting | Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer | Pre-operative single-dose radiotherapy (21 Gy) and BCSb | Physician reported cosmetic outcome | Ki-67, patient reported cosmetic outcome, gene expression, local control, circulating cell free DNA | March 2025 |