Breast Cancer (Invasive Carcinoma or Ductal Carcinoma In Situ - DCIS)
Conditions
Interventions
Intervention Group:Mastectomy of the nipple + preservation of the areola + simultaneous nipple reconstruction surgery
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, age >= 18 years, with full cognitive and behavioral capacity to provide informed consent. 2. Pathologically confirmed primary invasive carcinoma or ductal carcinoma in situ (DCIS) via core needle biopsy. 3. Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition). 4. Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction. 5. Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS. 6. ECOG performance status 0-1. 7. The patient is able to understand the study purpose, procedures, and potential risks, and voluntarily provides written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. High clinical or radiological suspicion of areola or skin involvement. 2. Inflammatory breast cancer. 3. Women who are pregnant or lactating. 4. Presence of severe, uncontrolled comorbidities (e.g., heart failure, liver or renal failure, etc.) such that, in the investigator's judgment, the expected survival is less than 5 years or the patient cannot tolerate surgery. 5. Presence of severe psychiatric disorders or cognitive impairment that precludes compliance with the study. 6. Concurrent participation in another interventional clinical study that may interfere with the assessment of the primary endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-Year Local Recurrence Rate;Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication occurrence rate;BREAST-Q score;Papillary height retention rate;A stratified analysis was conducted between the radiotherapy group and the non-radiotherapy group to evaluate the impact of the intervention.; | — |
Countries
China
Contacts
Public ContactWang Ke
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed