One-stage prepectoral implant versus two-stage expander-to-implant breast reconstruction after mastectomy and radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, double-cohort study enrolling more than 104 women with non-metastatic (cT1-3N0-3M0) breast cancer who require adjuvant radiotherapy. Participants will receive either immediate prepectoral one-stage implant reconstruction or a two-stage expander-to-implant reconstruction and will be followed through surgery, radiotherapy, and reconstruction completion. The primary endpoint is the patient-reported BREAST-Q score at 12 months after surgery, and secondary endpoints include reconstruction success rate, surgical complications, cosmetic evaluation by physicians, capsular contracture, nipple and skin sensation, and tumor safety. Study data will include baseline and post-operative BREAST-Q changes as well as objective complication and cosmetic outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan cacer hospital
  Henan, Henan, China Recruiting

Study contacts

• Study coordinator: xiuchun Chen
• Email: cxc701024@163.com
• Phone: 18603719919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.