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Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial

NCT06938360 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-04-22

No results posted yet for this study

Summary

This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins). The primary endpoint was local recurrence rate, with secondary endpoints including disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.

Conditions

Interventions

PROCEDURE

breast-conserving surgery combined with radiotherapy

The experimental group received breast-conserving surgery combined with radiotherapy

Sponsors & Collaborators

  • Shaanxi Provincial People's Hospital

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2028-02-20
Completion
2030-02-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938360 on ClinicalTrials.gov