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

NCT06938360 | Recruiting

• 1 other identifier: KY20242433-F-1
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

breast-conserving surgery

Outcome Measures

Primary Outcomes (1)

• Local recurrence rate (LRR)

  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 Outcomes (3)

• Disease-free survival (DFS)

  From enrollment to 3 years later or death

• Overall survival (OS)

  From enrollment to 3 years later or death

• Patient-reported outcomes (PRO)

  From enrollment to 3 years later

Study Arms (2)

Total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction)

NO INTERVENTION

Prosthetic implantation or autologous tissue transfer reconstruction was permitted

breast-conserving surgery combined with radiotherapy

EXPERIMENTAL

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

Interventions

breast-conserving surgery combined with radiotherapy PROCEDURE

The experimental group received breast-conserving surgery combined with radiotherapy

breast-conserving surgery combined with radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-70 years with primary breast cancer;
• Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
• TNM stage T1-2;
• Nodal stage N0-1;
• Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
• Paget's disease;
• Neoadjuvant chemotherapy permitted for eligible patients;
• Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
• Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
• Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
• Participants voluntarily signed informed consent forms and completed ethics review procedures.

You may not qualify if:

• Tumor-related characteristics
• Metastatic or bilateral breast cancer
• Inflammatory breast cancer
• Multicentric lesions
• Comorbidities/treatment history
• History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy (systemic/local)
• Major non-breast surgery within 4 weeks before enrollment (excluding diagnostic biopsy/PICC placement) without full recovery
• 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
• Allogeneic bone marrow/solid organ transplantation history or planned
• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• Shaanxi Provincial People's Hospital: collaborator
• Tang-Du Hospital: collaborator

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, 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

Central Study Contacts

Ju liang J L Zhang

CONTACT

029-84775271; vascularzhang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): February 20, 2028
• Study Completion (Estimated): February 20, 2030
• Last Updated: April 22, 2025

Record last verified: 2025-02

Locations

CN (1)