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

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

Eligibility

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.

Conditions3

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