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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Henan cacer hospital
RECRUITING
Henan
Contact Information
Primary
xiuchun Chen
cxc701024@163.com
18603719919
Backup
minhao Lv
lvminhao2004628@163.com
13838392355
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 104
Treatments
Immediate One-Stage Prepectoral Prosthetic Breast Reconstruction Cohort
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.
Delayed-Immediate Two-Stage Expander/Implant Breast Reconstruction Cohort
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).
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov