Clinical trial · Interventional
Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
NCT07657442CI-TRIAL-00115329not yet 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)
This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
Conditions
Conditions (2)
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 |
| Early Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial-breast irradiation | Radiation | — | UNRESOLVED |
| Whole-breast irradiation and tumor bed boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: High-risk group
- description
- Patients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present: * Age younger than 40 years. * Histology of invasive lobular carcinoma or micropapillary carcinoma. * Multifocal disease, defined as two or more breast tumor foci. * Tumor size greater than 3 cm. * Lymphovascular invasion. * Invasive carcinoma with an extensive intraductal component. * Estrogen receptor-negative disease. Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present: * Age younger than 40 years. * Histology of invasive lobular carcinoma or micropapillary carcinoma. * Multifocal breast tumor before treatment. * Lymphovascular invasion. * Pathologic stage ypT1-2N0.
- interventionNames
- Radiation: Whole-breast irradiation and tumor bed boost
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Low-risk group
- description
- Patients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria: ① Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease. ② Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease. Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0/isN0.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG performance status score of 0 to 2. * Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ. * Clinical stage cT0-2N0M0. * Underwent breast-conserving surgery. * Negative surgical margins greater than 2 mm. Exclusion Criteria: * Regional lymph node metastasis. * Distant metastasis. * Bilateral breast cancer. * Prior thoracic radiotherapy. * Life expectancy of less than 5 years. * Lactating or pregnant women.
References
Publications (0)
Data not yet available
No reference posted for this study.