Breast conserving surgery with intraoperative radiotherapy for early breast cancer
Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
This study is testing whether a new type of radiation given during breast-conserving surgery can help early breast cancer patients have fewer complications and better results compared to the standard radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 620 (estimated) |
| Ages | 55 Years and up |
| Sex | Female |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT06375798 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes the local recurrence rate, incidence of incision complications, and aesthetic outcomes of intraoperative radiotherapy (IORT) combined with breast-conserving surgery in early breast cancer patients. A total of 620 patients are included, with some receiving IORT and others undergoing whole breast irradiation (WBI) based on their preferences. The study aims to evaluate the effectiveness of IORT compared to traditional WBI in terms of patient outcomes and satisfaction. The treatment regimens are tailored based on postoperative pathology and immunohistochemical reports.
Who should consider this trial
Good fit: Ideal candidates are women aged 55 and older with HER2-negative invasive breast cancer or DCIS who wish to undergo breast-conserving surgery.
Not a fit: Patients with bilateral or multifocal breast cancer, previous breast cancer, or active connective tissue diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved local control of breast cancer and better cosmetic outcomes for patients.
How similar studies have performed: Other studies have shown promising results with intraoperative radiotherapy, suggesting potential benefits in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shijiazhuang, Hebei
- The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
Study contacts
- Study coordinator: cuizhi GENG, archiater
- Email: gengcuizhi@hotmail.com
- Phone: 135 0321 6325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.