Trial reportCancer medicine2023
Pembrolizumab plus chemotherapy in Japanese patients with triple-negative breast cancer: Results from KEYNOTE-355.
Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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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
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone for Asian patients with advanced triple-negative breast cancer: a phase III RCTs based meta-analysis.Frontiers in oncology · 2025Pooled it
- Pooled it
- Pembrolizumab for Early-Stage Triple-Negative Breast Cancer: KEYNOTE-522 Japan Subgroup Analysis.Cancer science · 2026Trial
- Pembrolizumab plus chemotherapy in Japanese patients with triple-negative breast cancer: Results from KEYNOTE-355.Cancer medicine · 2023Trial
- TLR7 signature of tumour innervation reveals two distinct pathways of triple-negative breast cancer progression.British journal of cancer · 2026Article
- Article
- Efficacy and safety of programmed cell death protein 1/programmed death-ligand 1 inhibitors combined with chemotherapy for breast cancer: a systematic review and meta-analysis.Translational cancer research · 2026Article
- Exosome-delivered METTL14 drives hypoxia-induced proliferation, metastasis, and glycolysis of breast cancer cells through regulating TRIM16-mediated FGF7 ubiquitination.Breast cancer research : BCR · 2025Article
- TRAIL induces cytokine production via the NFkB2 pathway promoting neutrophil chemotaxis and neutrophil-mediated immune-suppression in triple negative breast cancer cells.Cancer letters · 2025Article
- Cost-Effectiveness Analysis of Pembrolizumab Plus Chemotherapy Compared with Chemotherapy as First-Line Treatment for Advanced PD-L1-Positive Triple-Negative Breast Cancer from a Japanese Healthcare Perspective.Clinical drug investigation · 2025Article
- PD‑1/PD‑L1 inhibitor‑based immunotherapy in locally advanced or metastatic triple‑negative breast cancer: A meta‑analysis.Oncology letters · 2025Article
- Dual regulation of the cGAS-STING pathway: new targets and challenges for subtype-specific immunotherapy in breast cancer.Frontiers in oncology · 2025Review
- Targeting Sphingosine-1-Phosphate Signaling in Breast Cancer.International journal of molecular sciences · 2024Review
- Breaking Barriers: The Promise and Challenges of Immune Checkpoint Inhibitors in Triple-Negative Breast Cancer.Biomedicines · 2024Review
- Immune characteristics and clinical significance of peripheral blood lymphocytes in breast cancer.BMC cancer · 2024Article
- Efficacy and Safety of Paclitaxel-Based PD-1/PD-L1 Immunotherapies for Triple-Negative Breast Cancer: A Systematic Review and Network Meta-Analysis.Clinical Medicine Insights. Oncology · 2024Article
- Potential of Dietary HDAC2i in Breast Cancer Patients Receiving PD-1/PD-L1 Inhibitors.Nutrients · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 12 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pembrolizumab plus chemotherapy improved progression-free survival (PFS) and overall survival (OS) compared with placebo plus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer with tumor programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥10 in the global, phase 3, randomized controlled trial KEYNOTE-355. We report results for patients enrolled in Japan. Patients were randomized 2:1 to pembrolizumab 200 mg or placebo Q3W for 35 cycles plus chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine-carboplatin). Primary endpoints were PFS per RECIST version 1.1 by blinded independent central review and OS in patients with PD-L1 CPS ≥10, PD-L1 CPS ≥1, and the intention-to-treat (ITT) population. No alpha was assigned to this exploratory analysis. Eighty-seven patients were randomized in Japan (pembrolizumab plus chemotherapy, n = 61; placebo plus chemotherapy, n = 26), 66 (76%) had PD-L1 CPS ≥1, and 28 (32%) had PD-L1 CPS ≥10. Median time from randomization to data cutoff (June 15, 2021) was 44.7 (range, 37.2-52.9) months in the ITT population. Hazard ratios (HRs; 95% CI) for OS were 0.36 (0.14-0.89), 0.52 (0.30-0.91), and 0.46 (0.28-0.77) in the PD-L1 CPS ≥10, PD-L1 CPS ≥1, and ITT populations, respectively. HRs (95% CI) for PFS were 0.52 (0.20-1.34), 0.61 (0.35-1.06), and 0.64 (0.39-1.05). Grade 3 or 4 treatment-related adverse events occurred in 85% of patients in each group (no grade 5 events). Consistent with the global population, pembrolizumab plus chemotherapy tended to show improvements in OS and PFS with manageable toxicity versus placebo plus chemotherapy in Japanese patients and supports this combination in this setting.
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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.