Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
Female breast cancer patients aged 18 to 70 years.
Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.
ECOG performance status of 0-1.
Age >70 years.
Metastatic breast cancer (Stage IV) at initial diagnosis.
Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.
Tumor involvement of the nipple-areolar complex.
Single group
Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh
Procedure/SurgeryNipple-sparing subcutaneous mastectomy combined with an implant for immediate breast reconstruction will be performed according to standard clinical practice. The choice of incision will be at the surgeon's discretion. Intraoperatively, tissue from behind the nipple will be sent for frozen section histopathological examination. If the margin is positive, the nipple-areolar complex will be resected following safety principles. The 3D-printed biodegradable biological mesh will be used to wrap the silicone implant, which is then placed in the subcutaneous tissue. The wound will be soaked and irrigated with sterile distilled water and normal saline. After achieving thorough hemostasis, a drain will be placed, and the skin will be closed in layers.
postoperative cosmetic results and safety
Postoperative Cosmetic Outcome and Safety: Patient satisfaction will be scored using the reconstruction module of the Breast-Q questionnaire, which includes satisfaction with breasts, satisfaction with surgical outcome, and satisfaction with treatment. Satisfaction with breasts will be the primary endpoint of this study. After the BREAST-Q questionnaire is completed, its score, known as the Q-SCORE, will be calculated. The specific evaluation requires the use of Q-SCORE scoring software. The Breast-Q scale also includes scores for satisfaction with surgery, satisfaction with treatment, and health-related quality of life (QOL), covering physical, psychosocial, and sexual well-being. For all dimensions, a higher patient-reported score indicates higher satisfaction and better quality of life.In outcome of BREAST-Q questionnaire, BREAST-Q scales (domains) are scored on a 0-100 range, with higher scores indicating greater satisfaction or better health-related quality of life.
Recurrence-Free Survival (RFS)
Recurrence in the ipsilateral breast, chest wall, skin, or surgical scar confirmed by imaging is defined as "local recurrence day" on the date of the earliest imaging finding. If local recurrence is diagnosed based on clinical history and physical examination, the date of clinical determination is the "local recurrence day." If diagnosed by cytology or histopathology, the date of the earliest examination is the "local recurrence day." RFS is the time from the date of surgery to the date of disease recurrence or death. For patients with no observed recurrence or death, the follow-up is censored at the date of the last confirmation of no recurrence. An increase in tumor markers such as CEA alone is not sufficient to diagnose recurrence.
Disease-Free Survival (DFS)
The time from the date of surgery to the date of tumor recurrence (if the specific date of recurrence is unknown, the date of death due to the tumor is used). For patients with no observed recurrence or death, the follow-up is censored at the date of the last confirmation of no recurrence (last date of no recurrence confirmation: the last date of outpatient visit or examination).
Overall Survival (OS)
The time from the date of surgery to death from any cause (if death has not occurred, the time to the last follow-up). For surviving patients, the follow-up is censored at the date of the last confirmation of survival. For patients lost to follow-up, it is censored at the last date of confirmed survival before being lost.
Surgical Technical Safety (Complication Rate)
Intraoperative complications: Including but not limited to: intraoperative bleeding, major vessel injury, subcutaneous emphysema, hypercapnia, etc. The rate is calculated as the number of patients with any intraoperative complication divided by the total number of patients who underwent surgery. Postoperative complications: Including but not limited to: infection, skin flap or nipple-areolar complex necrosis, sensory abnormalities in the surgical area, mesh-related complications, etc. The rate is calculated as the number of patients with any postoperative complication divided by the total number of patients who underwent surgery. Unplanned reoperation rate: The proportion calculated as the number of patients undergoing unplanned reoperation divided by the total number of patients who underwent surgery.
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