Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 1: Motiva Flora® tissue expander
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.
干预措施: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy (Radiation)
Arm 2: Mentor® SILTEX™ BECKER™
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.
干预措施: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy (Radiation)
Collective I: subjects with adjuvant radiotherapy -
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.
干预措施: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy (Radiation)
Collective II: subjects without adjuvant radiotherapy
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
干预措施: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy (Radiation)
结局指标
主要结局
Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use.
时间窗: 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).
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.
Aesthetic outcome assessment by Breast Aesthetic Scale and tissue analysis
时间窗: 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).
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.
次要结局
未报告次要终点