Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
Recruiting · NCT06938360 · Interventional (participants receive a specific treatment) · Lead sponsor: Xijing Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Transmural myocardial infarction on ECG
- Uncontrolled hypertension (SBP\>180 mmHg and/or DBP\>100 mmHg)
- Reproductive status
- Pregnancy/lactation, or reproductive-aged women with:
- Positive baseline pregnancy test
- Refusal of effective contraception
- Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
- Other investigator-determined exclusionary conditions
Where it is running
1 location listed.
- Xijing hospital - Xi'an, Shaanxi, China