Trial reportFrontiers in immunology2026
A phase II clinical trial of neoadjuvant chemotherapy combined with immunotherapy and different radiotherapy fractionation regimens in HR+/HER2- breast cancer.
Trial report in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06639672 (Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer), which is not on this map. Not yet cited in PubMed.
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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.
Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer: A Phase II Study
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The modest neoadjuvant response in early-stage HR+/HER2- breast cancer necessitates novel treatment intensification strategies. While radiotherapy can enhance systemic efficacy via immune modulation, the optimal fractionation for integration with immunochemotherapy remains unknown. This multicenter phase II study aims to evaluate the feasibility, safety, and preliminary efficacy of Toripalimab combined with chemotherapy and tumor-directed radiotherapy, specifically investigating three distinct fractionation schedules. Methods: This prospective, multicenter, three-cohort exploratory study enrolls treatment-naïve patients with early-stage HR+/HER2- breast cancer. Participants receive neoadjuvant Toripalimab plus chemotherapy alongside image-guided radiotherapy restricted to the primary tumor. Cohorts are differentiated by fractionation regimen: Arm 1 (8 Gy × 3 fractions, total 24 Gy); Arm 2 (16 Gy single fraction); Arm 3 (0.5 Gy twice daily for 8 cycles, cumulative 8 Gy). A total of 45 patients (15 per cohort) will be enrolled. The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate, recurrence, survival outcomes (OS, EFS, DMFS, IDFS, IBTR), and safety. Conclusions: This exploratory study will provide feasibility, tolerability, and preliminary efficacy data for a novel multimodal neoadjuvant strategy combining different radiotherapy fractionation patterns with immunotherapy and chemotherapy. Given the descriptive analytical framework, findings are expected to be hypothesis generating and will inform the selection of radiotherapy schedules for future larger-scale randomized trials aimed at improving outcomes in HR+/HER2- breast cancer. Clinical trial registration: http://www.chictr.org.cn, identifier NCT06639672.
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