Comparison of Mastectomy Expander Trial

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Лучевая терапия 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:

Первичные конечные точки

• Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use. [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07434648 · EK Nr:1386/2024 · 104796386

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗