Immediate Implant Breast Reconstruction

Study Overview
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Brief Summary
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The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy

Detailed Description
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non applicable

Official Title
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Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: immediate implant breast reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed breast carcinoma Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation) Patients planned to receive postoperative chest wall irradiation Age ≥ 18 years old WHO performance status 0-1 Affiliation to a social security system Informed consent signed prior any study specific procedures Exclusion Criteria: Inflammatory breast cancer Tumors with extensive involvement of the skin Use of tissue expander Indication of postoperative chemotherapy Patients planned for bilateral mastectomy History of previously treated ipsilateral breast carcinoma Usual contraindications for ADM Medical debility precluding surgical treatment Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up). Pregnancy or breast feeding Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions Legal inability or restricted legal ability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate implant breast reconstruction<br>immediate implant breast reconstruction | Procedure: immediate implant breast reconstruction<br>* Eligible patients will undergo radical mastectomy with axillary lymph nodes sampling followed by immediate and single-stage breast reconstruction using the acellular dermal matrix Strattice™<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. | Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. Significant complication is defined as: Any event delaying RT (delay surgery/RT > 3 months) Any event preventing patients from receiving radiotherapy within 6 months after surgery | confirm the feasibility of the therapeutic sequence at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of Baker | The rate of Baker grades 3/4 capsular contracture | up to 36 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastectomy, reconstruction