Clinical trial · Interventional
Super Hypofractionated Irradiation for Whole Breast Treatment
Super Hypofractionated Irradiation for Whole Breast Treatment: a Prospective, Single-arm Trial
NCT04926766CI-TRIAL-00083987SHIFTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam radiotherapy using IMRT technique | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHF-WBI
- description
- 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
- interventionNames
- Radiation: External Beam radiotherapy using IMRT technique
Primary outcomes (1)
- measure
- Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (7)
- measure
- Cumulative complication rate of ≥Grade 2 Late Radiation-induced Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Aged ≥18 years old * breast conservation surgery * unilateral histologically confirmed invasive breast carcinoma or Ductal Carcinoma In Situ (DCIS) * For patients with invasive breast cancer，negative axillary lymph nodes or micrometastasis only * Karnofsky Performance Status ≥80, and Life expectancy of \>5 years * Histologically negative surgical margin for invasive breast carcinoma or a minimum negative margin width of ≥ 3mm for DCIS * Surgery wound healed without infection * ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor * Female patients of child-producing potential must agree to use effective contraception for up to 1 month before study treatment and the duration of study participation Exclusion Criteria: * Histological involvement of supraclavicular lymph node * Histologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes * Pregnant or lactating women * Severe non-neoplastic medical comorbidities * Diagnosis of non-breast malignancy within 5 years preceding enrollment (excluding lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix, Pulmonary adenocarcinoma in situ，which are permitted). * simultaneous contralateral breast cancer * Previous radiotherapy to the neck, chest and/or ipsilateral axillary region * Active collagen vascular disease * Definitive histological or radiologic evidence of distant metastatic disease * Evidence of T4 disease
References
Publications (1)
- DERIVEDZheng 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 Aug 1;125(5):1360-1367. doi: 10.1016/j.ijrobp.2026.02.233. Epub 2026 Feb 25. PMID 41759682