Clinical trial · Interventional
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
NCT02617043CI-TRIAL-00027317HF-WBI-SIBunknownPhase 2ClinicalTrials.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 study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.
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 |
|---|---|---|---|
| hypofractionated whole breast irradiation with simultaneously integrated boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HF-WBI
- description
- Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.
- interventionNames
- Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost
Primary outcomes (1)
- measure
- Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
- timeFrame
- 2 year
- description
- acute toxicity related to irradiation such as lung and skin
Secondary outcomes (6)
- measure
- acute radiation-induced toxicity assessed by CTCAE v4.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 18-60 years old * Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection * Pathologically confirmed invasive breast cancer * A pathological T1-2N0M0 tumor * Tumor bed is labeled with Titanium clips * Negative surgical margins * Written informed consent. Exclusion Criteria: * KPS\<70 * Treated with neoadjuvant chemotherapy * Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm) * With severe comorbidity * Previous breast cancer or other malignant tumor history * Previous radiotherapy for breast or thorax * Medical contraindication for radiotherapy * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.