Breast Implant; ComplicationsBLITE-01NCT03737500
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
A study testing B-Lite® light weight breast implant and Standard silicone-based breast implant in people with Breast Implant; Complications and Breast Implant Protrusion, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer
- What is being tested?
- B-Lite® light weight breast implant and Standard silicone-based breast implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnosis with indication of total mastectomy and breast reconstruction
- Indication of post-mastectomy radiation therapy
- Availability to be followed up for 24 months
- Signature of informed consent
Who cannot join
- Patients candidated to breast-conserving surgery
- Contraindicated breast reconstruction (severe comorbidities, unfavourable survival outcome expected, distant metastases)
- Patients affected by other solid malignancies
- Pregnancy
- Participation to other clinical studies in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Silicone-based Breast Implant vs. B-Lite® Light Weight Breast Implant for Reconstructive Surgery After Total Mastectomy and Post-Mastectomy Radiotherapy for Breast Cancer: a Randomized Clinical Trial
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Being tested
- B-Lite® light weight breast implant, Standard silicone-based breast implant
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Lite® light weight breast implantDevice
Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant
Standard silicone-based breast implantDevice
Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution
| Study group | Role | What they receive |
|---|---|---|
| Standard silicone-based breast implant | Active comparator | Participants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of standard silicone-based breast implant (i.e. the breast implant commonly used in our institution) Receives: Device: Standard silicone-based breast implant |
| B-Lite® light weight breast implant | Experimental | Participants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of B-Lite® light weight breast implant Receives: Device: B-Lite® light weight breast implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate of breast reconstruction
Need of re-intervention for breast implant removal for any cause (such as breast implant exposure)
Measured: 24 months
Secondary outcomes (5)
Overall complications rate
Occurrence of any complication at any time point, such as: capsular contracture, wound dehiscence, skin/soft tissues necrosis, inframammary fold break, implant exposure treated conservatively, hematoma, peri-prosthetic fluid collection, wound/implant infection
Measured: 24 months
Magnetic resonance imaging (MRI) of breast implant and surrounding tissues
MRI evaluation for skin/soft tissues thinning, capsular contracture, implant break, chronic seroma
Measured: 6 months
Change in cosmetic outcome
Objective evaluation of cosmetic outcome by jugular-nipple/areola complex (NAC) and NAC-inframammary fold distances to evaluate symmetry, objective evaluation of plastic surgeon with serial photographs
Measured: 1, 6, 12, 24 months
Change in Quality of life (QoL) measured with BIBCQ
QoL evaluation included patient's satisfaction with breast reconstruction using the Body Image after Breast Cancer Questionnaire (BIBCQ)
Measured: 6, 12, 24 months
Change in Quality of life (QoL) measured with BREAST-Q
QoL evaluation included patient's satisfaction with breast reconstruction, using the BREAST-Q score
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Jun 2018
- Primary completion30 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast Implant; ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Corsi, MD, Principal investigator, Istituti Clinici Scientifici Maugeri Spa SB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737500
- Sponsor's protocol ID
- ICS Maugeri - CE 2202
- Acronym
- BLITE-01
- Status last verified
- Mar 2023
- First submitted
- 5 Nov 2018
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Govrin-Yehudain J, Dvir H, Preise D, Govrin-Yehudain O, Govreen-Segal D. Lightweight breast implants: a novel solution for breast augmentation and reconstruction mammaplasty. Aesthet Surg J. 2015 Nov;35(8):965-71. doi: 10.1093/asj/sjv080. Epub 2015 Sep 1.
PubMed 26333989Christante D, Pommier SJ, Diggs BS, Samuelson BT, Truong A, Marquez C, Hansen J, Naik AM, Vetto JT, Pommier RF. Using complications associated with postmastectomy radiation and immediate breast reconstruction to improve surgical decision making. Arch Surg. 2010 Sep;145(9):873-8. doi: 10.1001/archsurg.2010.170.
PubMed 20855758Ascherman JA, Hanasono MM, Newman MI, Hughes DB. Implant reconstruction in breast cancer patients treated with radiation therapy. Plast Reconstr Surg. 2006 Feb;117(2):359-65. doi: 10.1097/01.prs.0000201478.64877.87.
PubMed 16462313EBCTCG (Early Breast Cancer Trialists' Collaborative Group); McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19.
PubMed 24656685Ho AY, Hu ZI, Mehrara BJ, Wilkins EG. Radiotherapy in the setting of breast reconstruction: types, techniques, and timing. Lancet Oncol. 2017 Dec;18(12):e742-e753. doi: 10.1016/S1470-2045(17)30617-4.
PubMed 29208440Baschnagel AM, Shah C, Wilkinson JB, Dekhne N, Arthur DW, Vicini FA. Failure rate and cosmesis of immediate tissue expander/implant breast reconstruction after postmastectomy irradiation. Clin Breast Cancer. 2012 Dec;12(6):428-32. doi: 10.1016/j.clbc.2012.09.001. Epub 2012 Oct 11.
PubMed 23062707Fowble B, Park C, Wang F, Peled A, Alvarado M, Ewing C, Esserman L, Foster R, Sbitany H, Hanlon A. Rates of Reconstruction Failure in Patients Undergoing Immediate Reconstruction With Tissue Expanders and/or Implants and Postmastectomy Radiation Therapy. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):634-41. doi: 10.1016/j.ijrobp.2015.02.031. Epub 2015 Apr 28.
PubMed 25936815
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Silicone-based Breast Implant vs. B-Lite® Light Weight Breast Implant for Reconstructive Surgery After Total Mastectomy and Post-Mastectomy Radiotherapy for Breast Cancer: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03737500
- Acronym / sponsor ID
- BLITE-01 / ICS Maugeri - CE 2202
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Nov 2018 (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.
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard silicone-based breast implant | Active comparator | Device: Standard silicone-based breast implantParticipants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of standard silicone-based breast implant (i.e. the breast implant commonly used in our institution) |
| B-Lite® light weight breast implant | Experimental | Device: B-Lite® light weight breast implantParticipants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of B-Lite® light weight breast implant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer diagnosis with indication of total mastectomy and breast reconstruction
- Indication of post-mastectomy radiation therapy
- Availability to be followed up for 24 months
- Signature of informed consent
Key exclusion criteria (5 listed)
- Patients candidated to breast-conserving surgery
- Contraindicated breast reconstruction (severe comorbidities, unfavourable survival outcome expected, distant metastases)
- Patients affected by other solid malignancies
- Pregnancy
- Participation to other clinical studies in the last three months
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 |
|---|---|---|
| B-Lite® light weight breast implantDefinitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant | Device | B-Lite® light weight breast implant |
| Standard silicone-based breast implantDefinitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution | Device | Standard silicone-based breast implant |
Primary outcome
Failure rate of breast reconstruction
Time frame: 24 months
Need of re-intervention for breast implant removal for any cause (such as breast implant exposure)
5 secondary outcomes
Overall complications rate
Time frame: 24 months
Magnetic resonance imaging (MRI) of breast implant and surrounding tissues
Time frame: 6 months
Change in cosmetic outcome
Time frame: 1, 6, 12, 24 months
Change in Quality of life (QoL) measured with BIBCQ
Time frame: 6, 12, 24 months
Change in Quality of life (QoL) measured with BREAST-Q
Time frame: 6, 12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Background: PubMed 26333989Govrin-Yehudain J, Dvir H, Preise D, Govrin-Yehudain O, Govreen-Segal D. Lightweight breast implants: a novel solution for breast augmentation and reconstruction mammaplasty. Aesthet Surg J. 2015 Nov;35(8):965-71. doi: 10.1093/asj/sjv080. Epub 2015 Sep 1.
- Background: PubMed 20855758Christante D, Pommier SJ, Diggs BS, Samuelson BT, Truong A, Marquez C, Hansen J, Naik AM, Vetto JT, Pommier RF. Using complications associated with postmastectomy radiation and immediate breast reconstruction to improve surgical decision making. Arch Surg. 2010 Sep;145(9):873-8. doi: 10.1001/archsurg.2010.170.
- Background: PubMed 16462313Ascherman JA, Hanasono MM, Newman MI, Hughes DB. Implant reconstruction in breast cancer patients treated with radiation therapy. Plast Reconstr Surg. 2006 Feb;117(2):359-65. doi: 10.1097/01.prs.0000201478.64877.87.
- Background: PubMed 24656685EBCTCG (Early Breast Cancer Trialists' Collaborative Group); McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19.
- Background: PubMed 29208440Ho AY, Hu ZI, Mehrara BJ, Wilkins EG. Radiotherapy in the setting of breast reconstruction: types, techniques, and timing. Lancet Oncol. 2017 Dec;18(12):e742-e753. doi: 10.1016/S1470-2045(17)30617-4.
- Background: PubMed 23062707Baschnagel AM, Shah C, Wilkinson JB, Dekhne N, Arthur DW, Vicini FA. Failure rate and cosmesis of immediate tissue expander/implant breast reconstruction after postmastectomy irradiation. Clin Breast Cancer. 2012 Dec;12(6):428-32. doi: 10.1016/j.clbc.2012.09.001. Epub 2012 Oct 11.
- Background: PubMed 25936815Fowble B, Park C, Wang F, Peled A, Alvarado M, Ewing C, Esserman L, Foster R, Sbitany H, Hanlon A. Rates of Reconstruction Failure in Patients Undergoing Immediate Reconstruction With Tissue Expanders and/or Implants and Postmastectomy Radiation Therapy. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):634-41. doi: 10.1016/j.ijrobp.2015.02.031. Epub 2015 Apr 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Fabio Corsi, MD principal investigator
Istituti Clinici Scientifici Maugeri Spa SB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Lite® light weight breast implant and Standard silicone-based breast implant in people with Breast Implant; Complications and Breast Implant Protrusion, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate of breast reconstruction (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737500, which also lists 7 linked publications.
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 20 Mar 2023.