Table 3 Summary of the clinical trials regarding pre-operative breast cancer radiotherapy in more than one fraction
Trial ID | Status | Title | Treatment | Description/endpoint | Primary outcome measure | Estimated/ actual primary completion date |
|---|---|---|---|---|---|---|
NCT04360330 | Recruiting | SABER study for selected early-stage BC | Stereotactic Ablative RT RT dose: 4 predefined dose levels (35 Gy, 40 Gy, 45 Gy, 50 Gy, in 5 fractions given on non-consecutive days, over a period of 2 weeks). Then standard of care surgery. | Find the most effective RT dose to give to BC in a shorter period of time, prior to surgery. Toxicity, cosmesis and quality of life will be assessed. | Find the recommended Phase 2 Dose of Pre-Operative SABER in terms of the highest dose level tested for which no more than 1 out of 6 patients experience DLT | August 2023 |
NCT04234386 | Recruiting | GammaPod Dose Escalation RT for early-stage BC | GammaPod Radiation RT dose: 4 predefined dose levels (21 Gy, 24 Gy, 27 Gy, 30 Gy). Then standard of care surgery. | Determine a safe and effective dose of pre-operative RT to treat early stage BC. Cosmesis and quality of life will be assessed. | Establish the single-fraction MTD and DLTs | December 2025 |
NCT03624478 | Recruiting | Hypofractionated RT in Treating Participants with BC before surgery | Hypofractionated RT RT dose: NS (5 consecutive days followed by standard of care surgery). | Assess the efficacy, toxicity, cosmetic outcome and pathologic changes of hypofractionated RT in treating breast cancer before surgery (phase II trial) | pCR | August 17, 2021 |
NCT03043794 | Recruiting | Study of Stereotactic RT for BC | Stereotactic RT RT dose: 21 Gy followed by standard of care surgery. | Assess the efficacy, toxicity, cosmetic outcome, quality of life, and translational correlates to preoperative stereotactic RT for low risk BC (phase II trial) | pCR | August 1, 2022 |