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

Официальное название

A Prospective, Single-center, Double-arm Clinical Study to Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Local recurrence free survival rate (LRFS) [Срок оценки: 3 years]
• Regional recurrence free survival rate (RRFS) [Срок оценки: 3 years]

Вторичные конечные точки (3)

• Disease free survival (DFS) [Срок оценки: 3 years]
• Distant metastasis free survival rate (DMFS) [Срок оценки: 3 years]
• Main complication rate [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT06817954 · BC-MCWIBR-20250205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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