Clinical trial · Observational
Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
NCT06375798CI-TRIAL-00095106recruitingClinicalTrials.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)
A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery.
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 |
| HER2-negative Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- IORT group
- description
- The IORT group received intraoperative radiotherapy with a regimen of 50-KV-X 20Gy/1f.If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.
- interventionNames
- Procedure: radiotherapy
- label
- WBI group
- description
- WBI group received whole milk external irradiation with a regimen of 50Gy/25f.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously.
- interventionNames
- Procedure: radiotherapy
Primary outcomes (1)
- measure
- LRFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥55 years old； 2. Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0； 3. Patients who are willing to preserve milk and intend to undergo breast-conserving surgery； 4. If invasive breast cancer is confirmed, the surgical margin negative ≥2mm should be met. If DCIS is confirmed, the surgical margin should be negative ≥3mm； 5. ER≥ 30% and PR≥ 1%, HER2 negative； 6. Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up. Exclusion Criteria: 1. Simultaneous diagnosis of bilateral or multifocal breast cancer； 2. Previous ipsilateral breast cancer and/or prior chest wall radiation therapy； 3. There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest； 4. The investigators did not consider the patient suitable for participation in any other conditions of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.