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
Recruiting now
Conditions studied: Breast Cancer Patients
In brief
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
Key facts
- Study ID
- NCT07037576
- Run by
- Henan Cancer Hospital
- People needed
- 104
- Starts
- 2025-05-20
- Expected to finish
- 2028-03-30
- Last updated by the study team
- 2025-06-25
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Henan cacer hospital — Henan, Henan, China (enrolling)
Full record on ClinicalTrials.gov
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