To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)

NCT06817954 | Recruiting

• 1 other identifier: BC-MCWIBR-20250205
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Endoscopic-assisted mastectomy and immediate breast reconstruction

Outcome Measures

Primary Outcomes (2)

• Local recurrence free survival rate (LRFS)

  Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.

  3 years

• Regional recurrence free survival rate (RRFS)

  Regional recurrence refers to the recurrence in the drainage area of ipsilateral internal mammary lymph nodes, axillary lymph nodes, or supraclavicular and infraclavicular lymph nodes.

  3 years

Secondary Outcomes (3)

• Disease free survival (DFS)

  3 years

• Distant metastasis free survival rate (DMFS)

  3 years

• Main complication rate

  3 years

Study Arms (2)

endoscopic-assisted mastectomy and immediate breast reconstruction

EXPERIMENTAL

endoscopic-assisted mastectomy and immediate breast reconstruction

Procedure: endoscopic-assisted mastectomy and immediate breast reconstruction

mastectomy and immediate breast reconstruction

EXPERIMENTAL

mastectomy and immediate breast reconstruction

Procedure: mastectomy and immediate breast reconstruction

Interventions

endoscopic-assisted mastectomy and immediate breast reconstruction PROCEDURE

endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer

endoscopic-assisted mastectomy and immediate breast reconstruction

mastectomy and immediate breast reconstruction PROCEDURE

conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer

mastectomy and immediate breast reconstruction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;
• Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm;
• There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;
• There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;
• Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
• Preoperative clinical manifestations and imaging data showed no distant metastasis;
• No history of breast cancer or other serious underlying diseases in the past;
• Karnofsky performance status score ≥ 70;
• Eastern Cooperative Oncology Group score ≤ 2 ;
• The surgical procedure includes endoscopic-assisted/conventional mastectomy, sentinel lymph node biopsy/axillary lymph node dissection and immediate breast reconstruction;
• Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up;
• No swallowing difficulties; No shoulder joint movement disorders;
• Complete clinical data.

You may not qualify if:

• Male breast cancer or inflammatory breast cancer;
• Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
• The clinical data is basically incomplete;
• Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
• Bilateral breast cancer surgery;
• Other surgical methods;
• Preoperative distant metastasis or supraclavicular lymph node dissection;
• Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
• The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
• Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Qiang Ding, Professor

CONTACT

13951731373; dingqiang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)