To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer

NCT ID: NCT06817954

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

endoscopic-assisted mastectomy and immediate breast reconstruction

endoscopic-assisted mastectomy and immediate breast reconstruction

Group Type: EXPERIMENTAL

endoscopic-assisted mastectomy and immediate breast reconstruction

Intervention Type: PROCEDURE

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

mastectomy and immediate breast reconstruction

mastectomy and immediate breast reconstruction

Group Type: EXPERIMENTAL

mastectomy and immediate breast reconstruction

Intervention Type: PROCEDURE

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

Interventions

endoscopic-assisted mastectomy and immediate breast reconstruction

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

Intervention Type: PROCEDURE

mastectomy and immediate breast reconstruction

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;

2. 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;

3. There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;

4. There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;

5. Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);

6. Preoperative clinical manifestations and imaging data showed no distant metastasis;

7. No history of breast cancer or other serious underlying diseases in the past;

8. Karnofsky performance status score ≥ 70;

9. Eastern Cooperative Oncology Group score ≤ 2 ;

10. The surgical procedure includes endoscopic-assisted/conventional mastectomy, sentinel lymph node biopsy/axillary lymph node dissection and immediate breast reconstruction;

11. Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up;

12. No swallowing difficulties; No shoulder joint movement disorders;

13. Complete clinical data.

Exclusion Criteria

1. Male breast cancer or inflammatory breast cancer;

2. Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;

3. The clinical data is basically incomplete;

4. Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;

5. Bilateral breast cancer surgery;

6. Other surgical methods;

7. Preoperative distant metastasis or supraclavicular lymph node dissection;

8. Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;

9. The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;

10. Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Ding, Professor

Role: CONTACT

dingqiang@njmu.edu.cn

13951731373

Facility Contacts

Qiang Ding, Professor

Role: primary

dingqiang@njmu.edu.cn

+8613951731373

Other Identifiers

BC-MCWIBR-20250205

Identifier Type: -

Identifier Source: org_study_id