Immediate Implant Breast Reconstruction

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Procedure: immediate implant breast reconstruction

• Registration Number: NCT02055937
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

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

non applicable

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Primary Completion: 2015-10
• Study Completion: 2018-05-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immediate implant breast reconstruction	immediate implant breast reconstruction	immediate implant breast reconstruction

Primary Outcome Measures

Name	Time	Method
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.	confirm the feasibility of the therapeutic sequence 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

Secondary Outcome Measures

Name	Time	Method
The rate of Baker	up to 36 months after surgery	The rate of Baker grades 3/4 capsular contracture

Trial Locations

Locations (1)

Institut régional du Cancer - Montpellier - Val d'Aurelle; 🇫🇷 Montpellier, France