Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer

Breast Cancer Clinical Trial

— BLITE-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737500
• Other study ID #: ICS Maugeri - CE 2202
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Implant Protrusion
• Breast Implant; Complications
• Breast Neoplasms
• Radiotherapy Side Effect

Intervention

Device:
• B-Lite® light weight breast implant
Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant
• Standard silicone-based breast implant
Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution

Locations

Country	Name	City	State
Italy	Breast Unit - Istituti Clinici Scientifici Maugeri Spa SB	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rate of breast reconstruction	Need of re-intervention for breast implant removal for any cause (such as breast implant exposure)	24 months
Secondary	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	24 months
Secondary	Magnetic resonance imaging (MRI) of breast implant and surrounding tissues	MRI evaluation for skin/soft tissues thinning, capsular contracture, implant break, chronic seroma	6 months
Secondary	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	1, 6, 12, 24 months
Secondary	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)	6, 12, 24 months
Secondary	Change in Quality of life (QoL) measured with BREAST-Q	QoL evaluation included patient's satisfaction with breast reconstruction, using the BREAST-Q score	6, 12, 24 months