🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07037576
Recruiting Observational

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 · tracked via the Priya Life Science China tracker
Sponsor
Henan Cancer Hospital
Phase
Observational
Started
2025-05-20
Last updated
2025-06-25

Condition(s) studied

Breast Cancer Patients

Investigational drug(s) / intervention(s)

Breast Reconstruction Surgery

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

Study 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

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Henan cacer hospital Henan Henan Recruiting

More Henan Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037576 on ClinicalTrials.gov ↗ ← All trials in China