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

NCT07037576 | Recruiting

• 1 other identifier: 2025-034
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Patients

Keywords

Breast cancer; Breast reconstruction surgery; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• BREAST-Q (Breast Reconstruction Module) Scores

  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.

  Preoperatively and at 1 Year Postoperatively

Secondary Outcomes (6)

• Breast Reconstruction Failure Rate

  1 Year Postoperatively

• Complication Profile:

  1 Year Postoperatively

• Physician-Assessed Aesthetic Outcome

  1 Year Postoperatively

• Capsular Contracture Assessment

  1 Year Postoperatively

• Nipple and Skin Sensation Assessment

  1 Year Postoperatively

Study Arms (2)

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.

Procedure: Breast Reconstruction Surgery

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).

Procedure: Breast Reconstruction Surgery

Interventions

Breast Reconstruction Surgery PROCEDURE

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

Also known as: radiation

Delayed-Immediate Two-Stage Expander/Implant Breast Reconstruction Cohort; Immediate One-Stage Prepectoral Prosthetic Breast Reconstruction Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treatment-naïve women with unilateral primary breast cancer (clinical stage cT1-3N0-3M0) scheduled for immediate prepectoral direct-to-implant reconstruction OR tissue expander/implant two-stage reconstruction, followed by adjuvant radiotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cacer hospital

Henan, Henan, 450008, China

RECRUITING

Related Publications (12)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Sbitany H, Gomez-Sanchez C, Piper M, Lentz R. Prepectoral Breast Reconstruction in the Setting of Postmastectomy Radiation Therapy: An Assessment of Clinical Outcomes and Benefits. Plast Reconstr Surg. 2019 Jan;143(1):10-20. doi: 10.1097/PRS.0000000000005140.

  PMID: 30589770 RESULT

• Garza RM, Paik KJ, Chung MT, Duscher D, Gurtner GC, Longaker MT, Wan DC. Studies in fat grafting: Part III. Fat grafting irradiated tissue--improved skin quality and decreased fat graft retention. Plast Reconstr Surg. 2014 Aug;134(2):249-257. doi: 10.1097/PRS.0000000000000326.

  PMID: 25068325 RESULT

• Cano SJ, Klassen AF, Scott AM, Cordeiro PG, Pusic AL. The BREAST-Q: further validation in independent clinical samples. Plast Reconstr Surg. 2012 Feb;129(2):293-302. doi: 10.1097/PRS.0b013e31823aec6b.

  PMID: 22286412 RESULT

• Voineskos SH, Nelson JA, Klassen AF, Pusic AL. Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery. Annu Rev Med. 2018 Jan 29;69:467-479. doi: 10.1146/annurev-med-060116-022831.

  PMID: 29414263 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• xiuchun chen

  Henan Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

xiuchun Chen

CONTACT

18603719919; cxc701024@163.com

minhao Lv

CONTACT

13838392355; lvminhao2004628@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-05

Locations

CN (1)