International journal of radiation oncology, biology, physics · 2026
Early Safety of Ultra-Hypofractionated Whole Breast Irradiation and Sequential Tumor Bed Boost for Early Breast Cancer (SHIFT): A Multicenter, Phase 2 Trial.
СтатьяМногоцентровое исследованиеКлиническое исследование II фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Zheng Si-Yue, Huang Jia-Qi, Xie Jin-Rong, Gan Lu, Yu Bo, Shi Yong-Gang, Jiang Juan, Zhang Jie, Dong Mei-Lian, Qi Wei-Xiang, Cai Gang, Cai Rong, Xu Cheng, Xu Hao-Ping, Qian Xiao-Fang, Zhang Yi-Bin, Cao Lu, Chen Jia-Yi
Аннотация
PURPOSE: The multicenter, single-arm, phase 2 SHIFT trial evaluated an ultra-hypofractionated radiation therapy regimen that completes both whole breast irradiation and a sequential tumor bed boost within 1.5 weeks, with the primary endpoint of acute toxicity.
METHODS AND MATERIALS: Patients at 4 tertiary hospitals in China aged 18 years or above with invasive breast carcinoma (pT1-3, N0-1mic, M0) or ductal carcinoma in situ after BCS were eligible. All enrolled patients underwent whole breast irradiation of 26 Gy in 5 fractions over 5 days. A sequential tumor bed boost of 10.4 Gy in 2 fractions over 2 days was at the discretion of the radiation oncologist. The primary endpoint was the incidence of grade ≥2 acute radiation-induced toxicity within 6 months after RT, including fatigue, dermatitis, and breast pain. This trial is registered at ClinicalTrials.gov (NCT04926766).
RESULTS: Between January 2021 and July 2023, recruitment of 217 patients has been completed, of whom 209 received tumor bed boost. Within 6 months after RT, 157 (72.4%) patients experienced G1 acute toxicity only, 16 (7.4%) patients experienced G2 acute toxicity, with no G3 events observed. No toxicity event was reported in 44 (20.3%) patients. At a median follow-up of 28.3 months, no severe toxicities were found in any patient at any time during follow-up. No locoregional recurrence, distant metastasis, or death occurred. Dosimetric analysis demonstrated high protocol compliance across all centers.
CONCLUSIONS: The integrated ultra-hypofractionated radiation therapy regimen is well-tolerated, with acute toxicity profiles confirming its favorable safety profile. Long-term follow-up is ongoing to assess late effects and efficacy.
METHODS AND MATERIALS: Patients at 4 tertiary hospitals in China aged 18 years or above with invasive breast carcinoma (pT1-3, N0-1mic, M0) or ductal carcinoma in situ after BCS were eligible. All enrolled patients underwent whole breast irradiation of 26 Gy in 5 fractions over 5 days. A sequential tumor bed boost of 10.4 Gy in 2 fractions over 2 days was at the discretion of the radiation oncologist. The primary endpoint was the incidence of grade ≥2 acute radiation-induced toxicity within 6 months after RT, including fatigue, dermatitis, and breast pain. This trial is registered at ClinicalTrials.gov (NCT04926766).
RESULTS: Between January 2021 and July 2023, recruitment of 217 patients has been completed, of whom 209 received tumor bed boost. Within 6 months after RT, 157 (72.4%) patients experienced G1 acute toxicity only, 16 (7.4%) patients experienced G2 acute toxicity, with no G3 events observed. No toxicity event was reported in 44 (20.3%) patients. At a median follow-up of 28.3 months, no severe toxicities were found in any patient at any time during follow-up. No locoregional recurrence, distant metastasis, or death occurred. Dosimetric analysis demonstrated high protocol compliance across all centers.
CONCLUSIONS: The integrated ultra-hypofractionated radiation therapy regimen is well-tolerated, with acute toxicity profiles confirming its favorable safety profile. Long-term follow-up is ongoing to assess late effects and efficacy.