Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
PEARL: A Phase Ib/II Biomarker Study of Adding Radiation Therapy to Pembrolizumab Before Neoadjuvant Chemotherapy in Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Toxicity profile and tolerability of immune checkpoint inhibitors for the treatment of early-stage breast cancer: a systematic review and meta-analysis.Breast (Edinburgh, Scotland) · 2026Pooled it
- Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ERNature medicine · 2026Trial
- Trial
- Unlocking the therapeutic potential of immuno-radiotherapy: insights from preclinical and clinical research.Oncoimmunology · 2026Review
- Breast cancer immunogenicity as a spectrum: evolving concepts and therapeutic implications.The Journal of clinical investigation · 2026Review
- Article
- Facts and Hopes in Radioimmunotherapy for Localized Stages of Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
- Efficacy and Safety of Neoadjuvant Stereotactic Body Radiotherapy (SBRT) Combined with Chemoimmunotherapy in Locally Advanced Breast Cancer: A Single-Center, Retrospective Pilot Study.Breast cancer (Dove Medical Press) · 2026Article
- Optimizing immunotherapy-radiotherapy synergy in triple-negative breast cancer: mechanisms, clinical evidence, and therapeutic windows.Frontiers in immunology · 2026Review
- Synergistic effects of radiotherapy and immunotherapy: improving oncological outcomes.Frontiers in immunology · 2026Review
- Immune Checkpoint Inhibitor Therapy in Hormone Receptor-Positive Breast Cancer.International journal of molecular sciences · 2025Review
- BRCA1 and 2 Mutations and Efficacy of Pembrolizumab-Based Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer: A Real-World Multicenter Analysis.Journal of clinical medicine · 2025Article
- Molecular subtype-driven disparities in intraoperative touch imprint cytology accuracy for sentinel lymph node assessment in clinically node-positive breast cancer treated with neoadjuvant chemotherapy.European journal of medical research · 2025Article
- Updates on radiotherapy-immunotherapy combinations: Proceedings of 8th Annual ImmunoRad Conference.Oncoimmunology · 2025Article
- An immunological mechanism of resistance to CDK4/6 inhibitors in HROncoimmunology · 2025Article
- IL-17A-secreting γδ T cells promote resistance to CDK4/CDK6 inhibitors in HRNature cancer · 2025Article
- Real world feasibility of combining pembrolizumab with radiotherapy in early triple negative breast cancer.Discover oncology · 2025Article
- Radiation therapy as a biological modifier of the breast cancer immune microenvironment.NPJ breast cancer · 2025Article
- The untapped potential of radiation and immunotherapy for hormone receptor-positive breast cancer.NPJ breast cancer · 2025Review
- Navigating the complexities of preoperative radiotherapy in breast reconstruction: a new paradigm?Gland surgery · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
purposeTo assess safety and immune biomarkers after preoperative radiation therapy (RT) and anti-PD1 therapy in breast cancer. MATERIALS AND
methodsA phase I/IIb trial of pembrolizumab with RT was conducted in patients with triple-negative breast cancer (TNBC) and hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. All received pembrolizumab followed by a second cycle + RT (anti-PD1/RT) of 24 Gy/three daily fractions delivered to the breast tumor and then neoadjuvant chemotherapy (NAC). Blood and tumor biopsies were obtained at baseline, after anti-PD1, and after anti-PD-RT. Coprimary end points were safety and change in tumor-infiltrating lymphocytes (TILs). Secondary end points were pathologic complete response (pCR), residual cancer burden (RCB) rates, and event-free survival (EFS).
resultsSixty-six patients with stage I-III breast cancer (54 TNBC, 12 HR+/HER2-) were enrolled. The median follow-up was 32 months. Safety end point was met. Incidence of grade ≥3 toxicities was 41%. The pCR rate was 59.2%, 33.3%, and 54.5% for the TNBC, HR+/HER2-, and entire cohort, respectively. A total of 77.8% of TNBC and 41.6% of HR+/HER2- had a near pCR (RCB 0-1). The 3-year EFS was 80%. In the entire cohort, PD-L1 expression increased after anti-PD1 (median Combined Positive Score [CPS], 7.49-23.20; 95% CI, -41.88 to -6.30;
conclusionPreoperative RT with pembrolizumab is safe and results in high pCR rates and 3-year EFS, despite the lack of pembrolizumab during NAC. PD-L1 and TILs may be predictive biomarkers for preoperative anti-PD1/RT response. Reduction in TILs after adding RT to anti-PD1 highlights the importance of treatment sequencing.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.