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

Hebei Medical University Fourth Hospital620 enrolled

Overview

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.

This is a single-center, open, prospective study. A total of 620 breast cancer patients meeting the exclusion criteria were included and assigned to the IORT group and the WBI group according to the patients' wishes. The IORT group received intraoperative radiotherapy with a regimen of 50-KF-x 20Gy/1f, and the WBI group received whole milk external irradiation with a regimen of 50Gy/25f. 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. The clinical standard treatment regimen (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.

Study Type

OBSERVATIONAL

Enrollment

620

Conditions

Breast Cancer HER2-negative Breast Cancer

Interventions

radiotherapyPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Outcomes

Primary Outcomes

LRFS

There was no local recurrence survival

Time frame: At least 5 years

Central Contacts

cuizhi GENG, archiater

CONTACT

135 0321 6325 gengcuizhi@hotmail.com

meiqi WANG, attending

CONTACT

186 3305 1639 maggie92320@hotmail.com

Data from ClinicalTrials.gov

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