Mastectomy and Breast ReconstructionCOMMETNCT07434648
Comparison of Mastectomy Expander Trial
A study testing intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy in people with Mastectomy and Breast Reconstruction and Tissue Expander Based Breast Reconstruction, run by Medical University Innsbruck.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction, Adjuvant Radiotherapy
- What is being tested?
- intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Assoc. Prof. PD. Dr. Dolores Wolfram-Raunicher, MBA Department contact
Assoc. Prof. PD. Dr. med. univ. Barbara Del-Frari Department o contact
About this study
Official title: Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial
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).
Read the 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
- Being tested
- intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy
- Keywords
- breast reconstruction, implant capsular fibrosis, tissue expander comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapyRadiation
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:
- efficacy and safety of therapeutic and prophylactic comparative tissue expander-based breast reconstruction
- structural and functional changes in comparative tissue expanders following exposure to radiotherapy vs. non-radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy and Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434648
- Sponsor's protocol ID
- EK Nr:1386/2024
- Other IDs
- 104796386
- Acronym
- COMMET
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT07434648
- Acronym / sponsor ID
- COMMET / EK Nr:1386/2024
- Conditions
- Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction, Adjuvant Radiotherapy, Long Term Outcome
- Keywords
- breast reconstruction, implant capsular fibrosis, tissue expander comparison
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Motiva Flora® tissue expander | Experimental | Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapyWithin 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. |
| Arm 2: Mentor® SILTEX™ BECKER™ | Experimental | Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapyIn 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. |
| Collective I: subjects with adjuvant radiotherapy - | Experimental | Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapyThe 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. |
| Collective II: subjects without adjuvant radiotherapy | Experimental | Radiation: intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapyPatients, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapyPatients 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 | Radiation | Arm 1: Motiva Flora® tissue expander, Arm 2: Mentor® SILTEX™ BECKER™, Collective I: subjects with adjuvant radiotherapy -, Collective II: subjects without adjuvant radiotherapy |
Primary outcome
Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use.
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assoc. Prof. PD. Dr. Dolores Wolfram-Raunicher, MBA Department contact
Assoc. Prof. PD. Dr. med. univ. Barbara Del-Frari Department o contact
Questions about this trial
What is this clinical trial studying?
A study testing intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy in people with Mastectomy and Breast Reconstruction and Tissue Expander Based Breast Reconstruction, run by Medical University Innsbruck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assoc. Prof. PD. Dr. Dolores Wolfram-Raunicher, MBA Department (43/512/504/82050, dolores.wolfram@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use. (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.