Actively Recruiting
To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-05-01
800
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.
CONDITIONS
Official Title
To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Negative pregnancy test and use of reliable contraception for premenopausal and perimenopausal patients
- Diagnosed breast cancer confirmed by core needle biopsy with unilateral surgery planned
- Tumor node metastasis stage 0 to III by AJCC 8th edition
- Tumor at least 1 cm from the nipple areolar complex, size 2-3 cm or reduced to 3 cm by neoadjuvant chemotherapy
- Lesion at least 8-10 mm from the skin
- No clinical or imaging evidence of tumor invasion to skin, chest wall, or nipple areola complex
- Indications for breast preservation but patient prefers reconstruction
- Preventive mastectomy for BRCA1/2 mutation carriers or other high-risk groups
- No distant metastasis by preoperative clinical and imaging data
- No history of breast cancer or serious underlying diseases
- Karnofsky performance status score ≥ 70
- Eastern Cooperative Oncology Group score ≤ 2
- Planned surgical procedure includes endoscopic-assisted or conventional mastectomy with lymph node biopsy/dissection and immediate reconstruction
- Ability to understand research, voluntarily consent, comply, and follow-up
- No swallowing difficulties or shoulder joint movement disorders
- Complete clinical data available
You will not qualify if you...
- Male breast cancer or inflammatory breast cancer
- Metastatic breast cancer (stage IV) or tumor invasion of skin, pectoralis major muscle, or nipple areola complex
- Incomplete clinical data
- Previous chemotherapy or tumor resection at external hospitals
- Bilateral breast cancer surgery
- Use of other surgical methods
- Preoperative distant metastasis or supraclavicular lymph node dissection
- Other malignant tumors or history of malignancy in last 5 years besides breast cancer
- Serious non-malignant diseases affecting compliance or putting patient at risk
- Dementia, intellectual disability, or mental illness preventing informed consent understanding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
Q
Qiang Ding, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here