Clinical trial NCT02055937: Immediate Implant Breast Reconstruction
Official title: Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: mastectomy, reconstruction
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.
timeFrame: confirm the feasibility of the therapeutic sequence at 6 months
Secondary outcomes:
measure: The rate of Baker
timeFrame: up to 36 months after surgery
Other outcomes:
measure: Cosmetic results
timeFrame: up to 36 months after surgery
measure: Functional results
timeFrame: up to 36 months after surgery
measure: The rate of patients requiring breast implant removal
timeFrame: up to 36 months after surgery
measure: Study of tolerance
timeFrame: up to 36 months after surgery
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer - Montpellier - Val d'Aurelle
Study officials:
References:
citation: 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.
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.