Mastectomy Expander-Based Reconstruction: Comparing Expander Options and Outcomes

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

In this trial, women undergoing mastectomy with planned tissue expander–based reconstruction are randomized to receive either unilateral or bilateral prepectoral expanders, with or without a GalaFLEX matrix, and with or without adjuvant radiotherapy as per standard care. The study tracks aesthetic outcomes, patient and clinician satisfaction, and health-related quality of life over about six months until the expander is removed for final implant placement. It also analyzes the physical characteristics of removed expanders to see if radiotherapy changes material properties, and explores immunological factors related to capsular hardening. Eligibility includes adult women with breast cancer or high-risk indications, able to participate in German-language procedures, and appropriate for prepectoral reconstruction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Inclusion criterion 6 only applies to subject with radiotherapy: Adjuvant radiotherapy as part of the breast cancer treatment plan
* Inclusion criterion 7 only applies to women of childbearing potential (WOCBP): negative urine pregnancy test, not breastfeeding

Exclusion Criteria:

* 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.

Where it's running

• Univ. Klinik für Plastische-, Rekonstruktive- und Ästhetische Chirurgie Innsbruck
  Innsbruck, Tyrol, Austria Recruiting

Study contacts

• Study coordinator: Dolores Wolfram-Raunicher, MBA Department, Assoc. Prof. PD. Dr. med. univ
• Email: dolores.wolfram@i-med.ac.at
• Phone: 43/512/504/82050

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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.