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The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, distant metastasis, death, contralateral breast cancer and quality of life.
Eligible breast cancer patients will receive SHF-WBI of 5.2 Gy in 5 fractions to ipsilateral whole breast within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of the radiation oncologist. All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. Patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, distant metastasis, death and quality of life.
Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after SHF-WBI comparing to hypofractionated whole breast irradiation(40-42.5Gy/15-16Fx) and lost rate of follow up of 10%. In total 217 patients are needed to be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHF-WBI | Experimental | Patients with an indication for whole breast irradiation will receive 5.2 Gy in 5 fractions to whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Beam radiotherapy using IMRT technique | Radiation | 2600cGy/ 5 fractions / 1 weeks to ipsilateral whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity | Within time from the beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation induced toxicities will be assessed and recorded using Common Terminology Criteria for Adverse Events (CTCAE) 5.0. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative complication rate of ≥Grade 2 Late Radiation-induced Toxicity | Within time from 6 months after completion of radiotherapy to 5 years after completion of radiotherapy, any late toxicity will be assessed and recorded using the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 5.0 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life-EORTC QLQ-C30 | Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30 | 6 months |
| Quality of Life-EORTC QLQ-C30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiayi Chen, PhD, MD | Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine | Study Chair |
| Lu Cao, PhD, MD | Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41759682 | Derived | Zheng SY, Huang JQ, Xie JR, Gan L, Yu B, Shi YG, Jiang J, Zhang J, Dong ML, Qi WX, Cai G, Cai R, Xu C, Xu HP, Qian XF, Zhang YB, Cao L, Chen JY. Early Safety of Ultra-Hypofractionated Whole Breast Irradiation and Sequential Tumor Bed Boost for Early Breast Cancer (SHIFT): A Multicenter, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2026 Feb 25:S0360-3016(26)00416-5. doi: 10.1016/j.ijrobp.2026.02.233. Online ahead of print. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale | The cosmetic outcomes will be evaluated at 6 months after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast | 6 months |
| Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale | The cosmetic outcomes will be evaluated at 5 years after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast | 5 years |
| Locoregional recurrence | any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area(including supraclavicular, infraclavicular or internal mammary lymph nodes) | 5 years |
| Distant metastasis free survival (DMFS) | The time from the date of enrollment to any recurrence of tumor at distant sites or death from any cause | 5 years |
| Invasive recurrence-free survival (IRFS) | The time from the date of enrollment to any invasive recurrence of tumor or death from any cause | 5 years |
| Overall survival | The time from the date of enrollment to the date of death from any cause | 5 years |
Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30
| 5 years |
| Quality of Life-EORTC QLQ-BR23 | Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23 | 6 months |
| Quality of Life-EORTC QLQ-BR23 | Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23 | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |