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
NCT ID: NCT07037576
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
104 participants
OBSERVATIONAL
2025-05-20
2028-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Breast Reconstruction Surgery
Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy
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).
Breast Reconstruction Surgery
Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy
Interventions
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Breast Reconstruction Surgery
Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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xiuchun chen
Role: STUDY_DIRECTOR
Henan Cancer Hospital
Locations
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Henan cacer hospital
Henan, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Chen chun
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2025-034
Identifier Type: -
Identifier Source: org_study_id
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