Immediate Implant Breast Reconstruction (ISIS)

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

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: immediate implant breast reconstruction

Detailed Description

non applicable

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • Institut régional du Cancer - Montpellier - Val d'Aurelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immediate implant breast reconstruction	Procedure: immediate implant breast reconstruction; 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™

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic results	Cosmetic results: assessed by both the surgeon and patient (patient satisfaction will be evaluated using a self-questionnaire). Photographs of the breast will be taken at different times (Pre / per / postoperative) and the picture analysis will be reviewed by an independent committee.	up to 36 months after surgery
Functional results	Functional results: patient satisfaction will be evaluated using a self-questionnaire	up to 36 months after surgery
The rate of patients requiring breast implant removal	The rate of patients requiring breast implant removal	up to 36 months after surgery
Study of tolerance	Study of the indesirable effect of the radiotherapy on the implant	up to 36 months after surgery

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

General Publications

• Christian CK, Niland J, Edge SB, Ottesen RA, Hughes ME, Theriault R, Wilson J, Hergrueter CA, Weeks JC. A multi-institutional analysis of the socioeconomic determinants of breast reconstruction: a study of the National Comprehensive Cancer Network. Ann Surg. 2006 Feb;243(2):241-9. doi: 10.1097/01.sla.0000197738.63512.23.
• Lambert K, Mokbel K. Does post-mastectomy radiotherapy represent a contraindication to skin-sparing mastectomy and immediate reconstruction: an update. Surg Oncol. 2012 Jun;21(2):e67-74. doi: 10.1016/j.suronc.2011.12.007. Epub 2012 Jan 30.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: mastectomy, reconstruction
• Other Study ID Numbers: VA2012/37; 2012-A01369-34 (Registry Identifier: RCB)