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

Henan Cancer Hospital

Status: Enrolling

Conditions: Breast Cancer Patients

Treatments: Procedure: Breast Reconstruction Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT07037576

2025-034

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

104 participants in 2 patient groups

Immediate One-Stage Prepectoral Prosthetic Breast Reconstruction Cohort

Description:

Patients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral prosthetic breast reconstruction are eligible for inclusion, regardless of mesh use (with or without mesh). Approaches including open, endoscopic, or robotic techniques are acceptable, provided that adjuvant radiotherapy is administered after permanent implant placement.

Treatment:

Procedure: Breast Reconstruction Surgery

Delayed-Immediate Two-Stage Expander/Implant Breast Reconstruction Cohort

Description:

Patients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with two-stage expander/implant breast reconstruction are eligible, provided that: Expander placement may be either prepectoral or subpectoral, Mesh use is optional (with or without acellular dermal matrix), Radiotherapy is administered with the expander in situ, Permanent implant exchange is performed ≥6 months after completing radiotherapy, The implant exchange procedure permits any approach (open, endoscopic, or robotic) and any plane/mesh configuration (prepectoral/subpectoral, with/without mesh).

Treatment:

Procedure: Breast Reconstruction Surgery