Breast Cancer
Conditions
Keywords
mastectomy, reconstruction
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
Interventions
PROCEDUREimmediate 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™
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The rate of Baker | up to 36 months after surgery | The rate of Baker grades 3/4 capsular contracture |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic results | up to 36 months after surgery | 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. |
| Functional results | up to 36 months after surgery | Functional results: patient satisfaction will be evaluated using a self-questionnaire |
| The rate of patients requiring breast implant removal | up to 36 months after surgery | The rate of patients requiring breast implant removal |
| Study of tolerance | up to 36 months after surgery | Study of the indesirable effect of the radiotherapy on the implant |
Countries
France
Outcome results
None listed