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

NCT06375798 · tracked via the Priya Life Science China tracker

Sponsor

Hebei Medical University Fourth Hospital

Phase

Observational

Started

2020-11-19

Last updated

2025-09-15

Condition(s) studied

Breast CancerHER2-negative Breast Cancer

Investigational drug(s) / intervention(s)

radiotherapy

radiotherapy: 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.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. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

55 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

LRFS — At least 5 years
There was no local recurrence survival

Trial sites (1)

Facility	City	Region	Status
The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06375798 on ClinicalTrials.gov ↗ ← All trials in China