---
title: Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)
nct_id: NCT01199354
overall_status: UNKNOWN
phase: PHASE2
sponsor: Clinique Clementville
study_type: INTERVENTIONAL
primary_condition: Breast Carcinoma
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01199354.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01199354"
ct_last_update_post_date: 2011-06-09
last_seen_at: "2026-05-12T06:21:20.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)

**Official Title:** 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.

**NCT ID:** [NCT01199354](https://clinicaltrials.gov/study/NCT01199354)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Clinique Clementville
- **Conditions:** Breast Carcinoma
- **Start Date:** 2010-07
- **Completion Date:** 2017-07
- **CT.gov Last Update:** 2011-06-09

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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...
```

## Interventions

- **Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.** (PROCEDURE) — Mastectomy, preservation of the skin envelope, removal of the nipple-areolar complex and dissection of the axillary lymph nodes followed by immediate reconstruction with autologous latissimus dorsi flap with or without prosthesis.

## Primary Outcomes

- **Incidence of skin necrosis** — 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

- **Rate of histological remission of the surgical specimen based on the anatomopathological examination**

## Locations (11)

- Polyclinique Urbain V, Avignon, France — _NOT_YET_RECRUITING_
- Polyclinique Urbain V, Avignon, France — _NOT_YET_RECRUITING_
- Centre Jean Perrin, Clermont-Ferrand, France — _NOT_YET_RECRUITING_
- Groupe Hospitalier Mutualiste Clinique les Eaux Claires, Grenoble, France — _NOT_YET_RECRUITING_
- Centre Léon Bérard, Lyon, France — _NOT_YET_RECRUITING_
- Institut Paoli Calmettes, Marseille, France — _NOT_YET_RECRUITING_
- Institut Paoli Calmettes, Marseille, France — _NOT_YET_RECRUITING_
- Clinique Clementville, Montpellier, France — _RECRUITING_
- CRLCC Val d'Aurelle, Montpellier, France — _NOT_YET_RECRUITING_
- Clinique Belledonne, Saint-Martin-d'Hères, France — _NOT_YET_RECRUITING_
- Institut Claudius Regaud, Toulouse, France — _NOT_YET_RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.polyclinique urbain v|avignon||france` — added _(2026-05-12)_
- `locations.centre jean perrin|clermont-ferrand||france` — added _(2026-05-12)_
- `locations.groupe hospitalier mutualiste clinique les eaux claires|grenoble||france` — added _(2026-05-12)_
- `locations.centre léon bérard|lyon||france` — added _(2026-05-12)_
- `locations.institut paoli calmettes|marseille||france` — added _(2026-05-12)_
- `locations.clinique clementville|montpellier||france` — added _(2026-05-12)_
- `locations.crlcc val d'aurelle|montpellier||france` — added _(2026-05-12)_
- `locations.clinique belledonne|saint-martin-d'hères||france` — added _(2026-05-12)_
- `locations.institut claudius regaud|toulouse||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01199354.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01199354*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*