Clinical trial · Interventional
Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients
NCT03411174CI-TRIAL-00089615completedN/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 study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
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 partial breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HF-PBI
- description
- Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.
- interventionNames
- Radiation: hypofractionated partial breast irradiation
Primary outcomes (1)
- measure
- The change of breast cosmetic outcome
- timeFrame
- Baseline, and three years after the completion of radiation therapy
- description
- The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
Secondary outcomes (6)
- measure
- Acute radiation-induced toxicity assessed by CTCAE v4.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age≥ 50 years * Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection * Negative surgical margins * Pathologically confirmed invasive breast cancer * A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2- * Tumor bed is labeled with Titanium clips * Received adjuvant hormonal treatment * No adjuvant chemotherapy * ECOG:0-1 * Written informed consent. Exclusion Criteria: * Age\<50 years * KPS\<70 * Treated with neoadjuvant chemotherapy * Treated or being treated with chemotherapy * 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 (1)
- DERIVEDZhang X, Wang X, Xu Z, Chu Y, Chen X, Zhang L, Meng J, Shi W, Yang Z, Mei X, Yu X, Zhang Z, Guo X, Mo M, Liu G, Wu J, Shao Z, Ma J. Hypofractionated partial breast irradiation after breast-conserving surgery for patients with early stage breast cancer in China Mainland: a single-arm prospective trial. Sci Rep. 2025 Jan 31;15(1):3869. doi: 10.1038/s41598-025-88600-5. PMID 39890895