Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- BREAST-Q (Breast Reconstruction Module) Scores
研究概览
简要总结
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients
详细描述
This study is a prospective, double-cohort study. It plans to enroll more than 104 patients with cT1-3N0-3M0 breast cancer for immediate prepectoral muscle prosthesis reconstruction or two-step breast reconstruction with expander/prosthesis, and they will receive postoperative radiotherapy. Record the changes of BREAST-Q scores of the patients before and after the operation, as well as information such as postoperative complications and capsular contracture.
The primary endpoint was the BREAST-Q score at 12 months after the operation. The secondary endpoints included the success rate of breast reconstruction, surgical complications, cosmetic effects of the breast evaluated by doctors, the occurrence of capsular contracture, nipple and skin sensation, and tumor safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18 to 70；
- •Newly diagnosed breast cancer patients showing no evidence of distant metastasis on clinical examination and diagnostic workup；
- •adjuvant radiotherapy is required;
- •Patients scheduled to undergo nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral implant-based reconstruction (via open, endoscopic, or robotic approach) require adjuvant radiotherapy AFTER permanent implant placement; OR Patients scheduled for NSM/SSM with two-stage tissue expander/implant reconstruction (with expander placement in either submuscular or prepectoral plane) receive radiotherapy WITH the tissue expander in situ, followed by exchange for permanent implant ≥6 months post-radiotherapy (expander position: submuscular/prepectoral acceptable; surgical approach: open/endoscopic/robotic acceptable);
- •Patients are eligible regardless of whether mesh is used in the reconstruction surgery;
- •Patients with severe breast ptosis are eligible;
- •During the study observation period, lipofilling is permitted on the affected breast and symmetrization procedures on the contralateral breast in both cohorts;
- •ECOG performance status 0-1;
- •Patients receiving neoadjuvant chemotherapy (NACT) are eligible;
- •Bilateral breast reconstruction is permitted;
- •No smoking history OR smoking cessation ≥4 weeks prior to enrollment;
- •Investigator-confirmed protocol compliance capability;
- •Concurrent participation in other interventional/non-interventional trials is allowed if deemed non-interfering by the investigator;
- •Voluntarily participate and sign the informed consent form after comprehensive understanding.
排除标准
- •Stage IV (metastatic) breast cancer;
- •No prior radiotherapy post-mastectomy;
- •History of ipsilateral chest wall/axillary radiation therapy;
- •Immunodeficiency, poorly controlled diabetes (HbA1c >7%), or active tobacco use;
- •Inflammatory breast cancer (cT4d);
- •Autologous-based breast reconstruction or delayed reconstruction;
- •Severe cardiopulmonary/hepatic/renal comorbidities contraindicating surgery/radiotherapy (ASA class ≥III);
- •Psychiatric disorders precluding independent BREAST-Q completion;
- •Pregnancy or lactation;
- •Documented history of protocol non-adherence;
- •Life-limiting comorbidities interfering with treatment OR investigator-determined ineligibility.
结局指标
主要结局
BREAST-Q (Breast Reconstruction Module) Scores
时间窗: Preoperatively and at 1 Year Postoperatively
This trial collects patient-reported outcomes through four domains of the BREAST-Q Breast Reconstruction Module: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being, Sexual Well-being. Scores are assessed preoperatively and at 12 months postoperatively. The BREAST-Q score at 12 months post-surgery serves as the primary endpoint.
次要结局
- Physician-Assessed Aesthetic Outcome(1 Year Postoperatively)
- Breast Reconstruction Failure Rate(1 Year Postoperatively)
- Complication Profile:(1 Year Postoperatively)
- Capsular Contracture Assessment(1 Year Postoperatively)
- Nipple and Skin Sensation Assessment(1 Year Postoperatively)
- Oncological Safety Endpoints: Disease-Free Survival (DFS) and Overall Survival (OS).(5 Year Postoperatively)