Breast Cancer Patients
Conditions
Keywords
Breast cancer, Breast reconstruction surgery, Radiotherapy
Brief summary
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
Detailed description
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.
Interventions
PROCEDUREBreast Reconstruction Surgery
Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy
Sponsors
Henan Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. women aged 18 to 70； 2. Newly diagnosed breast cancer patients showing no evidence of distant metastasis on clinical examination and diagnostic workup； 3. adjuvant radiotherapy is required; 4. 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); 5. Patients are eligible regardless of whether mesh is used in the reconstruction surgery; 6. Patients with severe breast ptosis are eligible; 7. During the study observation period, lipofilling is permitted on the affected breast and symmetrization procedures on the contralateral breast in both cohorts; 8. ECOG performance status 0-1; 9. Patients receiving neoadjuvant chemotherapy (NACT) are eligible; 10. Bilateral breast reconstruction is permitted; 11. No smoking history OR smoking cessation ≥4 weeks prior to enrollment; 12. Investigator-confirmed protocol compliance capability; 13. Concurrent participation in other interventional/non-interventional trials is allowed if deemed non-interfering by the investigator; 14. Voluntarily participate and sign the informed consent form after comprehensive understanding.
Exclusion criteria
1. Stage IV (metastatic) breast cancer; 2. No prior radiotherapy post-mastectomy; 3. History of ipsilateral chest wall/axillary radiation therapy; 4. Immunodeficiency, poorly controlled diabetes (HbA1c \>7%), or active tobacco use; 5. Inflammatory breast cancer (cT4d); 6. Autologous-based breast reconstruction or delayed reconstruction; 7. Severe cardiopulmonary/hepatic/renal comorbidities contraindicating surgery/radiotherapy (ASA class ≥III); 8. Psychiatric disorders precluding independent BREAST-Q completion; 9. Pregnancy or lactation; 10. Documented history of protocol non-adherence; 11. Life-limiting comorbidities interfering with treatment OR investigator-determined ineligibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BREAST-Q (Breast Reconstruction Module) Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Profile: | 1 Year Postoperatively | Includes but not limited to: Hematoma, Poor Wound Healing, Flap Necrosis, Surgical Site Infection, Wound Dehiscence, Fat Grafting-Associated Complications. All complications must be graded according to the Clavien-Dindo Classification System, then systematically assessed and documented. |
| Physician-Assessed Aesthetic Outcome | 1 Year Postoperatively | Evaluated by surgeons independent of the operating team using the Harris Scale to grade the aesthetic outcome of the reconstructed breast based on standardized patient photographs. |
| Breast Reconstruction Failure Rate | 1 Year Postoperatively | Breast Reconstruction Failure Rate: Defined as the proportion of patients requiring implant removal due to complications among all patients undergoing breast reconstruction. Implant Removal Due to Complications: Refers to explantation occurring within 12 months postoperatively attributed to any of the following surgery-related complications: Hematoma, Seroma, Flap necrosis, Nipple-areolar complex (NAC) necrosis, Surgical site infection, Wound dehiscence, Implant exposure, Baker grade III/IV capsular contracture, Implant malposition/displacement. Exclusion Criterion: Implant removals requested by patients without objective surgery-related complications (i.e., subjectively motivated explantations) must be documented separately and excluded from failure rate calculations. |
| Nipple and Skin Sensation Assessment | 1 Year Postoperatively | Tactile sensation is evaluated using the Semmes-Weinstein Monofilament Examination (SWME). |
| Oncological Safety Endpoints: Disease-Free Survival (DFS) and Overall Survival (OS). | 5 Year Postoperatively | DFS: Time interval from the date of surgery to the occurrence of any recurrence (local/regional/distant metastasis), new primary breast cancer, or death from any cause, whichever occurs first. Patients without events are censored at the last documented disease-free follow-up. OS: Time interval from the date of surgery to death from any cause. Living patients are censored at the last confirmed survival follow-up. |
| Capsular Contracture Assessment | 1 Year Postoperatively | Evaluated using the Baker Classification System (Spear & Baker, 1995). |
Countries
China
Contacts
Primary Contactxiuchun Chen
Backup Contactminhao Lv
Outcome results
None listed