Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer

Recruiting now

Conditions studied: Breast Cancer, HER2-negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT06375798

Run by

Hebei Medical University Fourth Hospital

People needed

620

Starts

2020-11-19

Expected to finish

2026-11-19

Last updated by the study team

2025-09-15

Who can join

Age: 55 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age ≥55 years old；
• Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0；
• Patients who are willing to preserve milk and intend to undergo breast-conserving surgery；
• 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；
• ER≥ 30% and PR≥ 1%, HER2 negative；
• Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up.

You may not qualify if…

• Simultaneous diagnosis of bilateral or multifocal breast cancer；
• Previous ipsilateral breast cancer and/or prior chest wall radiation therapy；
• There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest；
• The investigators did not consider the patient suitable for participation in any other conditions of the study.

Where it is running

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)

Full record on ClinicalTrials.gov

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