Clinical trial · Interventional
Immediate Implant Breast Reconstruction
Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy
NCT02055937CI-TRIAL-00046530ISISterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): autorities vorbidden this dispositif in other trial
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immediate implant breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- immediate implant breast reconstruction
- description
- immediate implant breast reconstruction
- interventionNames
- Procedure: immediate implant breast reconstruction
Primary outcomes (1)
- 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
- description
- 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 outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDChristian 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. PMID 16432358
- BACKGROUNDLambert 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. PMID 22296996