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

NCT06375798 | Recruiting

• 1 other identifier: 2020137
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; HER2-negative Breast Cancer

Keywords

Breast preservation surgery; Breast cancer invasion; radiotherapy

Outcome Measures

Primary Outcomes (1)

• LRFS

  There was no local recurrence survival

  At least 5 years

Study Arms (2)

IORT group

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.

Procedure: radiotherapy

WBI group

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.

Procedure: radiotherapy

Interventions

radiotherapy PROCEDURE

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.

IORT group; WBI group

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The clinical stage of Tis-1N0M0 in patients undergoing breast conserving surgery for early breast cancer

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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• cuizhi GENG, archiater

  Hebei Medical University Fourth Hospital

  STUDY DIRECTOR

Central Study Contacts

cuizhi GENG, archiater

CONTACT

135 0321 6325; gengcuizhi@hotmail.com

meiqi WANG, attending

CONTACT

186 3305 1639; maggie92320@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: November 19, 2020
• Primary Completion (Estimated): November 19, 2026
• Study Completion (Estimated): November 19, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

CN (1)