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
| NCT ID | NCT07037576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henan Cancer Hospital |
| Condition | Breast Cancer Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 104 participants in total. It began in 2025-05-20 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
xiuchun chen
STUDY DIRECTOR
Henan Cancer Hospital
Frequently Asked Questions
Who can join the NCT07037576 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07037576 currently recruiting?
Yes, NCT07037576 is actively recruiting participants. Contact the research team at cxc701024@163.com for enrollment information.
Where is the NCT07037576 trial being conducted?
This trial is being conducted at Henan, China.
Who is sponsoring the NCT07037576 clinical trial?
NCT07037576 is sponsored by Henan Cancer Hospital. The principal investigator is xiuchun chen at Henan Cancer Hospital. The trial plans to enroll 104 participants.
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