Evaluating endoscopic-assisted mastectomy with immediate breast reconstruction for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness and safety of a new endoscopic-assisted technique for mastectomy combined with immediate breast reconstruction in patients with breast cancer. The study is a prospective, single-center, double-arm trial that will compare the outcomes of this innovative approach against traditional methods. By utilizing advanced technology, the trial seeks to improve surgical outcomes and patient recovery times. The research is particularly focused on patients with specific tumor characteristics and stages, ensuring a targeted approach to treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Qiang Ding, Professor
• Email: dingqiang@njmu.edu.cn
• Phone: 13951731373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.