A phase II clinical trial of neoadjuvant chemotherapy combined with immunotherapy and different radiotherapy fractionation regimens in HR+/HER2- breast cancer - Summary - MDSpire
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A phase II clinical trial of neoadjuvant chemotherapy combined with immunotherapy and different radiotherapy fractionation regimens in HR+/HER2- breast cancer
To evaluate the feasibility, safety, and preliminary efficacy of Toripalimab combined with chemotherapy and tumor-directed radiotherapy in early-stage HR+/HER2- breast cancer.
Approach:
Study Design: This multicenter, three-cohort exploratory study enrolls treatment-naïve patients with early-stage HR+/HER2- breast cancer.
Intervention: Participants receive neoadjuvant Toripalimab plus chemotherapy and image-guided radiotherapy, differentiated by three fractionation regimens: 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).
Key Findings:
The primary endpoint is pathological complete response (pCR).
Secondary endpoints include objective response rate, recurrence, survival outcomes, and safety.
Interpretation:
The study will provide data on the feasibility, tolerability, and preliminary efficacy of a novel multimodal neoadjuvant strategy.
Limitations:
The study is exploratory and descriptive, limiting the generalizability of findings.
The sample size is small, with only 45 patients enrolled.
Conclusion:
This study aims to inform the selection of radiotherapy schedules for future trials.
