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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy

NCT06119633

Breast Cancer

COMPLETED NA

Assessment of Safety & Efficacy of Light Weight Breast Implant

NCT01874652

Breast Implants

COMPLETED PHASE2

Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

NCT03730922

Breast Neoplasm Female Complication of Radiation Therapy Breast Implant; Complications

RECRUITING NA

Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study

NCT00690339

Breast Augmentation Breast Reconstruction Revision of Augmentation or Reconstruction

COMPLETED NA

Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques

NCT04356235

Mastectomy; Lymphedema Breast Cancer Quality of Life

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type ACTIVE_COMPARATOR

Standard silicone-based breast implant

Intervention Type DEVICE

Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution

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

Group Type EXPERIMENTAL

B-Lite® light weight breast implant

Intervention Type DEVICE

Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

B-Lite® light weight breast implant

Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant

Intervention Type DEVICE

Standard silicone-based breast implant

Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No