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RECRUITING

NCT06938360

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

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2025-02-20

Completion Date

2030-02-20

Last Updated

2025-04-22

Healthy Volunteers

Conditions

Breast Cancer

Interventions

PROCEDURE

breast-conserving surgery combined with radiotherapy

The experimental group received breast-conserving surgery combined with radiotherapy

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

Locations (1)

Xijing hospital

Xi'an, Shaanxi, China