Immediate Implant Breast Reconstruction

Breast Cancer Clinical Trial

— ISIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02055937
• Other study ID #: VA2012/37
• Secondary ID: 2012-A01369-34
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Est. completion date: May 30, 2018

Study information

• Verified date: August 2020
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

non applicable

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: May 30, 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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™

Locations

Country	Name	City	State
France	Institut régional du Cancer - Montpellier - Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Functional results	Functional results: patient satisfaction will be evaluated using a self-questionnaire	up to 36 months after surgery
Other	The rate of patients requiring breast implant removal	The rate of patients requiring breast implant removal	up to 36 months after surgery
Other	Study of tolerance	Study of the indesirable effect of the radiotherapy on the implant	up to 36 months after surgery
Primary	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	The rate of Baker	The rate of Baker grades 3/4 capsular contracture	up to 36 months after surgery