Table 3. Preoperative and adjuvant radiotherapy and immune checkpoint blockade clinical trials in breast cancer.
cT1, clinical T1 tumor (tumor size ≤2 cm); HR+/HER2−, hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer; HT, neoadjuvant hormone therapy; IORT, intraoperative radiotherapy; LN+, lymph node-positive; NAC, neoadjuvant chemotherapy; NCT, national clinical trial; RT, radiation therapy; TNBC, triple negative breast cancer
| NCT Number | Phase | N | Status | Tumor Type | Intervention | Sponsor |
|---|---|---|---|---|---|---|
| Preoperative Trials | ||||||
| NCT02977468 | 1 | 15 | Recruiting | TNBC | Pembrolizumab + IORT | Columbia University |
| NCT03366844 | 1/2 | 60 | Recruiting | TNBC or HR+/HER2− | Pembrolizumab + RT (24 Gy in 3 fractions) | Cedars-Sinai Medical Center |
| NCT03804944 | 2 | 100 | Recruiting | HR+/HER2− | HT + Pembrolizumab + CDX-301 (Flt3 ligand) + RT (24 Gy in 3 fractions) | Weill Medical College of Cornell University |
| NCT03872505 | 2 | 140 | Not yet recruiting | TNBC | Durvalumab ± RT (24 Gy in 3 fractions) + Chemotherapy | Cedars-Sinai Medical Center |
| NCT04443348 | 2 | 120 | Not yet recruiting | TNBC or high-risk HR+/HER2− (grade 2-3 or high genomic assay score) | No RT or 9 Gy in 3 fractions or 24 Gy in 3 fractions + Chemotherapy + Pembrolizumab with exploratory proton cohort | Massachusetts General Hospital (TBCRC) |
| NCT04454528 | 1/2 | 36 | Not yet recruiting | TNBC or HR+/HER2− or HER2+ cT1 | Surgery ± Pembrolizumab ± RT | University of Pennsylvania |
| Adjuvant Trials | ||||||
| NCT02954874 | 3 | 1,000 | Recruiting | TNBC with residual disease after NAC | RT ± Pembrolizumab | National Cancer Institute |
| NCT03818685 | 2 | 114 | Recruiting | TNBC with residual disease after NAC | RT + Ipilimumab and Nivolumab OR Capecitabine | Centre Léon Bérard |