Table 4.
Ongoing preoperative RT trials.
| NCT Number | Locations | Type of Study | Patients | N Estimated |
Description | Time to Surgery | Objectives | Status |
|---|---|---|---|---|---|---|---|---|
| WBI | ||||||||
|
NCT05512286 (CAPPELLA) |
Guangxi, China | Randomized phase III | cT0-3, T4b and cN0-3a | 80 | Radiotherapy followed by mastectomy and DIEP flap reconstruction vs. radiotherapy after mastectomy and DIEP flap reconstruction | 2–6 weeks | Patient satisfaction | Not yet recruiting |
| NCT05412225 | New York, NY, USA | Phase II | cT4 cN0-3 | 60 | T4 M0 breast cancer patients with complete or partial response to standard neoadjuvant chemotherapy and immediate autologous reconstruction | 2–6 weeks | Wound complications | Recruiting |
| NCT05274594 | Istanbul, Turkey | Phase II | cT1-3 cN + | 37 | WBI + RNI: 42.5 Gy/16fx or 50 Gy/25fx or 50.4 Gy/28fx | 6 weeks | Pathologic complete response | Completed |
|
NCT04261244 (NEORAD) |
Duesseldorf, Germany | Randomized phase III | cT2-T4 (non-inflammatory) cT1, if G3, * triple negative, Her2 positive, or cN+ |
1826 | Preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy vs. postoperative radiotherapy after neoadjuvant chemotherapy | 3–8 weeks | DFS | Not yet recruiting |
| NCT03624478 | Scottsdale, Jacksonville, Rochester, NY, USA | Phase II | cT0-T2 cN0 | 25 | Preoperative ultra-hypofractionated WBI | 4–16 weeks | Pathologic complete response | Active, not recruiting |
| NCT02858934 | Brussels, Dendermonde, Belgium | Phase II | cT1-2N0M0 | 24 | WBI 25 Gy in 5 daily fractions of 5 Gy, SIB 30 Gy in 5 daily fractions of 6 Gy | 1 week | Duration of surgical procedure, blood loss, wound complications | Completed |
| APBI | ||||||||
|
NCT01014715 (GCC 0919) |
Baltimore, MD, USA | Phase II | Tc1-2 cN0 | 32 | Preoperative radiation followed by lumpectomy | 3 weeks | Reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers | Completed |
| NCT05464667 | Pittsburgh, PA, USA | Phase I/II | cTis-1 cN0 Luminal | 24 | Dose Escalation: 5 Cohorts—30 Gy in 5 fractions (baseline treatment with 0 boost dose to GTV), 35, 40, 45, 50 Gy in 5 fractions (Part 1) Dose Expansion: Maximum Tolerated Dose determined during dose escalation (Part 2) |
NR | Maximum tolerated dose | Not yet recruiting |
| NCT02316561 (ABLATIVE-1) | Amsterdam, Netherlands | Phase II | cT1 cN0 (<50y) cT1-2 (≤3 cm) cN0 (>70y) | 25 | Single dose of 20 Gy/15 Gy on the gross tumor volume and clinical tumor volume respectively | 24 weeks | Pathologic complete response | Completed |
|
NCT05350722 (ABLATIVE-2) |
Amsterdam, The Netherlands | Phase II | cTis-1 cN0 Luminal | 100 | Single dose of 20 Gy/15 Gy on the gross tumor volume and clinical tumor volume respectively | 24 weeks | Pathologic complete response | Recruiting |
|
NCT05217966 (SPtedORT-DNS) |
Montreal, QC, Canada | Phase II | cTis-1 cN0 Luminal | 80 | Single Pre-Operative Radiation Therapy | 52 weeks | Pathologic complete response | Recruiting |
|
NCT04679454 (CRYSTAL) |
Milan, Italy | Phase I/II | cT1-T2 (up to 2.5 cm) cN0 | 79 | Phase I: 3 dose levels:18 Gy, 21 Gy and 24 Gy in single fraction phase II: clinical evaluation |
4–8 weeks | Phase I: maximum tolerated dose Phase II: pathologic complete response of selected dose |
Recruiting |
|
NCT04360330 (SABER) |
Miami, FL, USA | Phase I | cT1 cN0 Luminal | 18 | Preoperative SABR Phase I study testing up to 4 dose levels: 35 Gy (5 fractions of 7 Gy); 40 Gy (5 fractions of 8 Gy); 45 Gy (5 fractions of 9 Gy); 50 Gy (5 fractions of 10 Gy) | 4–6 weeks | Recommended dose for a phase II | Recruiting |
|
NCT03875573 (NEO-CHECK-RAY) |
Brussels, Belgium | Randomized phase II | cT2 zN0 or cT1 cN1-3 Luminal B HER2- |
147 | Preoperative 3 × 8 Gy with chemotherapy ± durvalumab ± oleclumab | 2–6 weeks | Immune related or radiation therapy related toxicity | Recruiting |
| NCT02728076 | Milwaukee, WI, USA | Phase II | Clinically stage I-II | 40 | Preoperative MRI-based radiation followed by lumpectomy | 5–8 weeks | Postoperative complications | Active, not recruiting |
| NCT02482376 | Durham, CN, USA | Phase II | cTis-1 cN0 Luminal | 68 | Single fraction of 21 Gy of stereotactic radiotherapy before proceeding to surgery. | 2–4 weeks | Physician reported rates of good/excellent cosmesis | Active, not recruiting |
|
NCT02065960 (ARTEMIS) |
Hamilton, ON, Canada | Phase II | cT1 cN0 Luminal | 32 | SABR to a dose of 40 Gy in 5 fractions delivered every other day over a period of 10–12 days, followed by breast conserving surgery | 8–12 weeks | Feasibility | Unknown status |
| ANTICIPATED BOOST | ||||||||
|
NCT05603078 (BIRKIN) |
Beijing, China | Phase II | cT1-4 cN0 | 102 | Preoperative MRI-guided tumor-bed boost and post-operative ultra-hypofractionated radiotherapy (26 Gy/5.2 Gy/5) | 4 weeks | Primary endpoint: acute toxicities; secondary endpoints: oncologic outcomes, surgical complications within 30 days, late toxicities, patients’ quality of life and cosmetic outcomes. | Recruiting |
| NCT04871516 | New Brunswick, NJ, USA | Phase II | Clinical stage 0-IIIC | 55 | Anticipatedboost in 4 fractions | 1–3 weeks | Wound complications | Recruiting |
| NCT03366844 | Los Angeles, CA, USA | Phase I/II | T2-4c cN0-3 any subtype | 60 | Anticipated boost 3 × 8 Gy + pembrolizumab | 6 weeks | Feasibility and changes in tumor-infiltrating lymphocytes (TIL) | Active, not recruiting |
| NCT03804944 | New York (NY), Pittsburh (PA), Houston (TX), USA | Randomized Phase III | Clinical stage II-III ER + HER2- | 100 | Anticipated boost 3 × 8 Gy + letrozole ± pembrolizumab or Ftl-3 ligand or pembrolizumab + Ftl-3 ligand | 14 weeks | Feasibility, clinical response, pathologic response | Active, not recruiting |
|
NCT03359954 (PRECISE) |
Houston, TX, USA | Phase II | cT1-4 cN0-3 Luminal | 25 | Anticipated boost | 1 week | Changes in tumor-infiltrating lymphocytes (TIL) | Active, not recruiting |
WBI: whole breast irradiation; RNI: regional node irradiation; APBI: accelerated partial breast irradiation; MRI: magnetic resonance image; SABR:stereotactic ablative breast radiotherapy; SIB: simultaneous boost integrated; DFS: disease-free survival; Flt-3L: FMS-related tyrosine kinase 3 ligand.