Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer (BLITE-01)
March 17, 2023 updated by: Istituti Clinici Scientifici Maugeri SpA
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pavia, Italy
- Breast Unit - Istituti Clinici Scientifici Maugeri Spa SB
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard silicone-based breast implant
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)
|
Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution
|
|
Experimental: B-Lite® light weight breast implant
Participants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of B-Lite® light weight breast implant
|
Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall complications rate
Time Frame: 24 months
|
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
|
24 months
|
|
Magnetic resonance imaging (MRI) of breast implant and surrounding tissues
Time Frame: 6 months
|
MRI evaluation for skin/soft tissues thinning, capsular contracture, implant break, chronic seroma
|
6 months
|
|
Change in cosmetic outcome
Time Frame: 1, 6, 12, 24 months
|
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
|
1, 6, 12, 24 months
|
|
Change in Quality of life (QoL) measured with BIBCQ
Time Frame: 6, 12, 24 months
|
QoL evaluation included patient's satisfaction with breast reconstruction using the Body Image after Breast Cancer Questionnaire (BIBCQ)
|
6, 12, 24 months
|
|
Change in Quality of life (QoL) measured with BREAST-Q
Time Frame: 6, 12, 24 months
|
QoL evaluation included patient's satisfaction with breast reconstruction, using the BREAST-Q score
|
6, 12, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fabio Corsi, MD, Istituti Clinici Scientifici Maugeri Spa SB
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Christante 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.
- Ascherman 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.
- Ho 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.
- Baschnagel 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.
- Fowble 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.
- EBCTCG (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. Erratum In: Lancet. 2014 Nov 22;384(9957):1848.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
November 5, 2018
First Submitted That Met QC Criteria
November 8, 2018
First Posted (Actual)
November 9, 2018
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 17, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICS Maugeri - CE 2202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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