Comparison of Mastectomy Expander Trial

NCT07434648 | Not Yet Recruiting DMC

• 2 other identifiers: EK Nr:1386/2024104796386
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

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

Keywords

breast reconstruction; implant capsular fibrosis; tissue expander comparison

Outcome Measures

Primary Outcomes (2)

• Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use.

  Breast magnetic resonance imaging (MRI) will be routinely performed before surgery (diagnostic MRI, OP1 - Baseline). MRI and Ultrasound will be study specific performed before radiotherapy at Screening, Visit 5 (pre RT Coll 1, ), Visit7 (pre OP2 Coll1) and Visit 5 (pre OP2 Coll 2). Furthermore in order to analyze skin flap thickness, seroma formation, expander and port dislocation the thickness of the capsule formed around the expanders at defined spots (12 o'clock, 3, 6 and 9 o'clock). Additionally, some patients 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.

  It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Average trial duration per subject will be: 33,5 months; Duration of follow-up-phase is 2 years (FU1-12 months; FU2-24 months).

• Aesthetic outcome assessment by Breast Aesthetic Scale and tissue analysis

  For comparative analysis of the aesthetic outcome, the applyed standardized "Breast Aesthetic scale" assessment tool by evaluating standardized preoperative and postoperative photo documentation will be used. Additionaly BIS (Body Image Scale), EORTC-QLQ-SH22, BREAST-Q are patient-reported outcome measures (PROM). Capsular tissue will be excised two times 6x2cm at OP2, if patients have Mentor expanders implanted.

  It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Average trial duration per subject will be: 33,5 months; Duration of follow-up-phase is 2 years (FU1-12 months; FU2-24 months).

Study Arms (4)

Arm 1: Motiva Flora® tissue expander

EXPERIMENTAL

Within the first operation (OP 1, visit 1), 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, with native tissue ingrowth through its poly-4-hydroxybutyrate (P4HB)-based open-pore monofilament structure, providing immediate supplemental soft tissue repair support and long-term strength. Matrix/Scaffold are only needed for fixation of Mentor expanders, not for Motiva Flora expander. The Motiva Flora® Tissue Expanders also includes two fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket.

Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy

Arm 2: Mentor® SILTEX™ BECKER™

EXPERIMENTAL

In case of MENTOR™ SILTEX™ BECKER™ expanders, the MENTOR™ TRUE-LOCK™ Connector is designed to join the preinserted or preattached fill tube of the Mentor expander to the injection dome. Once the MENTOR™ SILTEX™ BECKER™ expanders are expanded to the desired volume, the fill tube and injection dome will not be removed through a small incision under local anesthetic, instead the fill tube and injection dome are kept in situ, until the expander is replaced with the definitive implant. Therefore no additional operation is needed and the risk for infections will be reduced.

Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy

Collective I: subjects with adjuvant radiotherapy -

EXPERIMENTAL

The decision regarding the adjuvant radiotherapy following breast implantation is be made by the surgeon and the radiation oncologist before inclusion into the study. Radiotherapy planning and dose constraints will be based on CT stimulation and will be scheduled according to therapeutic guidelines. The radiotherapy will be conducted routinely for three weeks (every week: 5 days with 2 days break). Pre-radiotherapy clinical examination (visit 5) and post-radiotherapy clinical examination (visit 6) is planned after the expander inflation 2.

Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy

Collective II: subjects without adjuvant radiotherapy

EXPERIMENTAL

Patients, who will not receive adjuvant radiotherapy, will not attend to visit "pre-radiotherapy clinical examination" and visit "post-radiotherapy clinical examination". For this collective II, visit 5 will be the preparation for final breast reconstruction (OP 2). But if there is a need for adjuvant radiotherapy based on interdisciplinary tumor board desicion (at Visit 1, Visit 2 or Visit 3), Subject will change from Collectove 2 to Collective 1

Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy

Interventions

intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy RADIATION

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

Arm 1: Motiva Flora® tissue expander; Arm 2: Mentor® SILTEX™ BECKER™; Collective I: subjects with adjuvant radiotherapy -; Collective II: subjects without adjuvant radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women undergo therapeutic or prophylactic uni- or bilateral, skin or nipple-sparing mastectomy with prepectoral expander-based breast reconstruction with and without adjuvant radiotherapy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understands and agrees to comply with the study procedures and provides informed consent as documented by signature
• Female subjects aged ≥ 18 years at time of consent
• INDICATION: Breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy OR ductal carcinoma in situ (DCIS) diagnosis without neoadjuvant chemotherapy AND / OR positive genetic counseling for high-risk family history of breast cancer
• RECONSTRUCTION MODALITIES: planned uni- or bilateral NSME or SSME with simultaneous prepectoral tissue expander-based breast reconstruction due to malignancy OR Planned prophylactic bilateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction. Planned unilateral NSME or SSME and planned prophylactic contralateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction
• Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said or written.

You may not qualify if:

• Subject with implanted device that may be affected by magnetic fields (pacemaker)
• Known presence of HIV, viral hepatitis (patient-reported)
• Presence of autoimmune disease(s) or immunocompromised subject due to immunosuppressive or steroid therapy
• The subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study.

Sponsors & Collaborators

• Medical University Innsbruck: lead

MeSH Terms

Interventions

Methods; Appointments and Schedules; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Investigative Techniques; Organization and Administration; Health Services Administration; Combined Modality Therapy; Therapeutics

Central Study Contacts

Assoc. Prof. PD. Dr. Dolores Wolfram-Raunicher, MBA Department

CONTACT

43/512/504/82050; dolores.wolfram@i-med.ac.at

Assoc. Prof. PD. Dr. med. univ. Barbara Del-Frari Department o

CONTACT

43/512/504/80899; barbara.del-frari@tirol-kliniken.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 25, 2026

Record last verified: 2026-02