Table 2 Current trials registered on clinicaltrials.gov for radiotherapy + immunotherapy in HR+ breast cancer
From: The untapped potential of radiation and immunotherapy for hormone receptor-positive breast cancer
NCT Identifier | Site | Phase, Estimated enrolment | Trial Status | Key Eligibility | Treatment | RT details and timing | Key Endpoint(s) |
|---|---|---|---|---|---|---|---|
Neo-adjuvant/Adjuvant Setting | |||||||
Jules Bordet Institute | 2, n = 147 | Phase 2 ongoing, not recruiting (Safety run-in complete) | Luminal B HR+/HER2-Mammaprint high-risk, Ki67 ≥ 15% or grade 3 | 1:1:1 NACT + NART boost, ±Durvalumab (anti-PD-L1), ±Oleclumab (anti-CD73) | 3x 8Gy to primary tumour using SBRT over 3–6 days, concurrent with Durvalumab ±Oleclumab | Primary: Safety, surgical feasibility, tumour response (RCB 0-I vs II–III) in primary + nodes Secondary: Cosmetic changes, 3-year iDFS, AE duration + severity, ypT0/ypN0 | |
P-RAD NCT04443348 | Massachusetts General Hospital | 2, n = 120 | Recruiting | cN+, TNBC or high-risk HR+/HER2- (high risk = G2-3 or high genomic assay score) | 1:1:1 Pembrolizumab (anti-PD-1) + 0/9/24 Gy NART, followed by NACT + Pembrolizumab | 3x 3 Gy or 3x 8 Gy over 3 days to primary tumour. Includes proton option for 3x 8 Gy patients. RT before and concurrent with Pembrolizumab | Primary: TILs, ypN0 Secondary: RCB, TILs, PD-L1 expression, AEs, iDFS, EFS |
CBCV NCT03804944 | Weill Cornell Medicine | 2, n = 100 | Recruiting | Post-menopausal Stage II–III HR+/HER2- | NET (letrozole) for 4 months + randomised 1:1:1:1 to NART alone or with Pembrolizumab (anti-PD-1) or CDX-301 (FLT-3 ligand) or both | 3x 8 Gy to primary tumour over 5–6 days. Pembrolizumab starting final day of RT | Primary: Clinical + pathological response (RCB 0-1 vs. 2-3), toxicity Secondary: TILs, blood PBMCs |
BreastVAX NCT04454528 | Abramson Cancer Center of the University of Pennsylvania | 1b/2, n = 27 | Recruiting | Localised, Any receptor status, not for NACT | 1:1:1:1 NART boost then Pembrolizumab (anti-PD-1), Pembrolizumab then NART boost, Pembrolizumab only, Controls (surgery only) | 1x 7 Gy. Pembrolizumab before or after RT | Primary: Feasibility, clinical/pathological response Secondary: Ki67 + CD8 T-cells (tumour + blood) |
NCT06402435 | Hubei Cancer Hospital | 2, n = 50 | Recruiting | Non-metastatic HR+/HER2- | Neo-adj RT + Ivonescimab (AK112; bispecific anti-PD1/VEGF) + chemotherapy | 3x 8 Gy SBRT to primary alone, or 3x 6 Gy SBRT to primary + axillary metastases | Primary: pCR Secondary: ORR, EFS |
NCT02971748 | M.D. Anderson Cancer Center | 2, n = 37 | Active, Not Recruiting | Inflammatory breast cancer, HR+/HER2- | Pembrolizumab (anti-PD-1) + hormone therapy if no pCR to NACT | Post-mastectomy RT before or concurrent with pembrolizumab | Primary: 2-year DFS Secondary: OS, AEs |
NCT06639672 | West China Hospital | 2, n = 60 | Not yet recruiting | Non-metastatic HR+/HER2- | Neo-adj chemotherapy + anti-PD1 + RT | Non-randomised; RT dosing 3x 8 Gy, 1x 16 Gy, 15×2.67 Gy, or 12-18×0.5 Gy | Primary: pCR Secondary: OS, locoregional recurrence |
Metastatic Setting | |||||||
NCT04616248 | University of Southern California | 1, n = 18 | Recruiting | Metastatic solid tumours including HER2- breast cancer | CDX-301 (FLT3 ligand) + CDX-1140 (anti-CD40) + Poly ICLC (synthetic dsRNA) + RT | RT to target lesion, dose/fractionation not specified | Primary: MTD, safety Secondary: CD4, CD8, myeloid cells, PD-L1 expression |
NCT04683679 | Memorial Sloan Kettering Cancer Centre | 2, n = 34 | Recruiting | Metastatic/recurrent TNBC and HR+/HER2- | Pembrolizumab (anti-PD-1) + Olaparib (PARP inhibitor) + RT | RT to target lesion (primary or metastasis) 3 × 8–9 Gy SBRT or 6x 5 Gy | Primary: ORR |
SOLARA NCT04711824 | Hoosier Cancer Research Network | 1–2, n = 41 | Recruiting | Brain metastases TNBC or HER2- breast cancer with BRCA mutation, | Olaparib (PARP inhibitor) + SRS, followed by SACT (physician’s choice) + durvalumab (anti-PD-L1) | SRS 1–5 fractions, dose per local institution | Primary: AEs, intracranial DCR Secondary: Intracranial PFS, OS, intracranial ORR, extracranial PFS |
NCT03449238 | Weill Cornell | 1–2, n = 41 | Recruiting | ≥2 Brain metastases Any receptor type | Pembrolizumab (anti-PD-1) day 4 (±1) post-SRS | SRS | Primary: Intracranial abscopal effects, OS Secondary: Extracranial abscopal effects |
UPCC 23915 NCT02639026 | Abramson Cancer of the University of Pennsylvania | 1, n = 53 | Complete | Metastatic tumours including breast cancer (can be HR+) | Durvalumab (anti-PD-L1) + tremelimumab (anti-CTLA4) + RT | 3x 8 Gy or 1x 17 Gy to metastatic lesion | Primary: AEs |
