Clinical trial · Interventional
Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)
Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.
NCT01199354CI-TRIAL-00004975M-RICunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of skin necrosis
- description
- To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy.
Secondary outcomes (1)
- measure
- Rate of histological remission of the surgical specimen based on the anatomopathological examination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Women \< 75 year old * Invasive breast carcinoma, indication for mastectomy * Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier... Exclusion Criteria: * Women older than 75 * Metastatic breast carcinoma * Antecedents of previously treated homolateral breast carcinoma * Documented cancer progression * Smoker at the moment of the indication surgery * Known diabetes, neoadjuvant hormonal treatment...
References
Publications (0)
Data not yet available
No reference posted for this study.