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Recruiting NCT07037576

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

— Observational Breast Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breast Reconstruction Surgery.
Who it may be relevant to
Registry conditions: Breast Cancer Patients. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Procedure Breast Reconstruction Surgery
    Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy

Primary outcome measures

  • BREAST-Q (Breast Reconstruction Module) Scores [Time frame: Preoperatively and at 1 Year Postoperatively]
Secondary outcome measures (6)
  • Breast Reconstruction Failure Rate [Time frame: 1 Year Postoperatively]
  • Complication Profile: [Time frame: 1 Year Postoperatively]
  • Physician-Assessed Aesthetic Outcome [Time frame: 1 Year Postoperatively]
  • Capsular Contracture Assessment [Time frame: 1 Year Postoperatively]
  • Nipple and Skin Sensation Assessment [Time frame: 1 Year Postoperatively]
  • Oncological Safety Endpoints: Disease-Free Survival (DFS) and Overall Survival (OS). [Time frame: 5 Year Postoperatively]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Henan cacer hospital — Henan

Publications

  • Kraenzlin F, Chopra K, Kokosis G, Venturi ML, Mesbahi A, Nahabedian MY. Revision Breast Reconstruction with Prepectoral Pocket Conversion of Submuscular Breast Implants. Plast Reconstr Surg. 2021 May 1;147(5):743e-748e. doi: 10.1097/PRS.0000000000007885. PMID 33890886
  • Chatterjee A, Nahabedian MY, Gabriel A, Macarios D, Parekh M, Wang F, Griffin L, Sigalove S. Early assessment of post-surgical outcomes with pre-pectoral breast reconstruction: A literature review and meta-analysis. J Surg Oncol. 2018 May;117(6):1119-1130. doi: 10.1002/jso.24938. Epub 2018 Jan 18. PMID 29346711
  • Li Y, Xu G, Yu N, Huang J, Long X. Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction: A Meta-analysis. Ann Plast Surg. 2020 Oct;85(4):437-447. doi: 10.1097/SAP.0000000000002190. PMID 31913902
  • Sigalove S. Prepectoral breast reconstruction and radiotherapy-a closer look. Gland Surg. 2019 Feb;8(1):67-74. doi: 10.21037/gs.2019.01.01. PMID 30842930
  • Gabriel A, Maxwell GP. Prepectoral Breast Reconstruction in Challenging Patients. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):14S-21S. doi: 10.1097/PRS.0000000000004046. PMID 29166343
  • Chopra S, Al-Ishaq Z, Vidya R. The Journey of Prepectoral Breast Reconstruction through Time. World J Plast Surg. 2021 May;10(2):3-13. doi: 10.29252/wjps.10.2.3. PMID 34307092
  • Clemens MW, Kronowitz SJ. Acellular dermal matrix in irradiated tissue expander/implant-based breast reconstruction: evidence-based review. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):27S-34S. doi: 10.1097/PRS.0b013e318265f690. PMID 23096982
  • Kronowitz SJ, Hunt KK, Kuerer HM, Babiera G, McNeese MD, Buchholz TA, Strom EA, Robb GL. Delayed-immediate breast reconstruction. Plast Reconstr Surg. 2004 May;113(6):1617-28. doi: 10.1097/01.prs.0000117192.54945.88. PMID 15114121

Identifiers

NCT: NCT07037576 · 2025-034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗