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

April 14, 2025 updated by: Xijing Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, open-label, multicenter, randomized clinical trial plans to enroll 158 patients with primary central early-stage breast cancer. Participants will be randomly assigned to two groups: the control group undergoing total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), and the experimental group receiving breast-conserving surgery with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement is present; conversion to total mastectomy required for intraoperative or postoperative positive margins). All enrolled patients will initiate surgical treatment within 24 hours after eligibility confirmation. Experimental group patients must complete preoperative breast ultrasound, mammography, and MRI to assess breast-conserving feasibility. All patients receive standardized adjuvant therapy (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy) according to guidelines. Those meeting neoadjuvant therapy criteria may receive preoperative systemic treatments (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy), excluding neoadjuvant radiotherapy.

Primary Endpoint:

local recurrence rate

Secondary Endpoints:

disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.

Inclusion Criteria:

  1. Female patients aged 18-70 years with primary breast cancer;

  2. Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:

    • TNM stage T1-2;
    • Nodal stage N0-1;
  3. Ductal carcinoma in situ (DCIS) with maximum tumor diameter <3 cm;
  4. Paget's disease;
  5. Neoadjuvant chemotherapy permitted for eligible patients;
  6. Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
  7. Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
  8. Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
  9. Participants voluntarily signed informed consent forms and completed ethics review procedures.

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged 18-70 years with primary breast cancer;

  2. Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:

    • TNM stage T1-2;
    • Nodal stage N0-1;
  3. Ductal carcinoma in situ (DCIS) with maximum tumor diameter <3 cm;
  4. Paget's disease;
  5. Neoadjuvant chemotherapy permitted for eligible patients;
  6. Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
  7. Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
  8. Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
  9. Participants voluntarily signed informed consent forms and completed ethics review procedures.

Exclusion Criteria:

  1. Tumor-related characteristics

    1. Metastatic or bilateral breast cancer
    2. Inflammatory breast cancer
    3. Multicentric lesions

  2. Comorbidities/treatment history

    1. History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy (systemic/local)
    2. Major non-breast surgery within 4 weeks before enrollment (excluding diagnostic biopsy/PICC placement) without full recovery

    3. Active infections/immune disorders:

      HIV/AIDS Viral hepatitis (HBV-DNA≥500 IU/ml; HCV antibody-positive with detectable HCV-RNA) Autoimmune hepatitis HBV/HCV coinfection

    4. Allogeneic bone marrow/solid organ transplantation history or planned

    5. Cardiovascular diseases:

      • Heart failure or LVEF<50%
      • Uncontrolled arrhythmias (resting heart rate>100 bpm, ventricular tachycardia, Mobitz II/third-degree AV block)
      • Angina requiring antianginal drugs
      • Clinically significant valvulopathy
      • Transmural myocardial infarction on ECG
      • Uncontrolled hypertension (SBP>180 mmHg and/or DBP>100 mmHg)

  3. Reproductive status

    Pregnancy/lactation, or reproductive-aged women with:

    • Positive baseline pregnancy test
    • Refusal of effective contraception
  4. Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
  5. Other investigator-determined exclusionary conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction)
Prosthetic implantation or autologous tissue transfer reconstruction was permitted
Experimental: 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
Procedure: breast-conserving surgery combined with radiotherapy
The experimental group received breast-conserving surgery combined with radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence rate (LRR)
Time Frame: From enrollment to 3 years later or death
Local recurrence rate (LRR) was defined as tumor recurrence in the ipsilateral breast, chest wall, skin, or surgical scar area.
From enrollment to 3 years later or death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: From enrollment to 3 years later or death
Disease-free survival (DFS) was defined as the time from randomization to the first occurrence of any of the following events: ipsilateral/contralateral breast cancer recurrence; local/regional recurrence; distant metastasis; or all-cause death.
From enrollment to 3 years later or death
Overall survival (OS)
Time Frame: From enrollment to 3 years later or death
Overall survival (OS) was defined as the time interval from enrollment to all-cause death.
From enrollment to 3 years later or death
Patient-reported outcomes (PRO)
Time Frame: From enrollment to 3 years later
Patient-reported outcomes (PRO) were assessed using the BREAST-Q Cosmetic Module, with scores ranging from 0 to 100 (higher scores indicating better cosmetic outcomes).
From enrollment to 3 years later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Shaanxi Provincial People's Hospital
Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

February 20, 2028

Study Completion (Estimated)

February 20, 2030

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20242433-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on breast-conserving surgery combined with radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe