NCT07434648

Comparison of Mastectomy Expander Trial

Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy/expander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer. Requested answers: * how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment, * how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants, * how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material, * which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).

Detailed description

Breast cancer-diagnosed patients and patients undergoing prophylactic mastectomy will undergo unior bilateral tissue expander breast reconstruction. Participants will be screened and only after the eligibility is confirmed, the patients will be included and randomized in either receiving prepectoral uni- or bilateral MRI-conditional: Arm 1 or Arm 2 TE. Within the first operation patients will receive an expander (=inflatable silicone implant) to increase the amount of tissue available for breast reconstruction. The expander is positioned in the subcutaneous plane combined with or without a GalaFLEX™ matrix, a biologically derived 2D scaffold. The suture is removed (visit 2) and the expander is stepwise filled in 2-3 visits (visit 3 and 4, an optional visit 4b might be necessary). The two study arms are further divided in subjects with adjuvant radiotherapy (collective I) or without adjuvant radiotherapy (collective II) according standard of care. The decision regarding the adjuvant radiotherapy following breast implantation is be made by the surgeon and the radiation oncologist before inclusion into the study. If subjects from collective II need an adjuvant radiotherapy based on interdisciplinary tumorboard decision after OP 1 (pretherapeutical nodal + patients and/or on definitive histological findings in mastectomy specimens/axillary lymphnodes), subjects will switch from collective II to collective I. After 6 months, the expander is removed and a permanent silicone breast implant is placed (exchange expander to definitive implant or autologous tissue; OP 2). Two clinical follow-up visits will be scheduled 12 and 24 months after the second operation.

Conditions

• Mastectomy and Breast Reconstruction
• Tissue Expander Based Breast Reconstruction
• Adjuvant Radiotherapy
• Long Term Outcome

Interventions

Type	Name	Description
RADIATION	intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy	Patients who are scheduled for tissue expander-based breast reconstruction will be randomized in one of two expander groups (Arm 1= Motiva Flora® Tissue Expander \& Arm 2 = SILTEX™ BECKER™ expander). Subjects, who are routinely scheduled for radiotherapy (collective I) will subsequently undergo two additional visits. Subjects without scheduled radiotherapy (collective II), will continue without additional visits - unless they need to change their collective for therapeutic reasons. Assesments: 1. efficacy and safety of therapeutic and prophylactic comparative tissue expander-based breast reconstruction 2. structural and functional changes in comparative tissue expanders following exposure to radiotherapy vs. non-radiotherapy

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-31
• Completion: 2031-12-31
• First posted: 2026-02-25
• Last updated: 2026-02-25