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Status unknownNCT01199354M-RICUpdated Jun 9, 2011

Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)

A Phase 2 interventional study of Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap. in Breast Carcinoma, sponsored by Clinique Clementville. Status unknown at 11 sites in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-06-09.

Sponsored by Clinique Clementville · Phase 2 and Interventional

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Carcinoma

Keywords

  • Invasive breast carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 80 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with Clinique Clementville as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts 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

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...
05

Study design

Phase
Phase 2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

  • ProcedureMastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.

    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.

06

What researchers measure

Primary outcomes

  1. 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

  1. Rate of histological remission of the surgical specimen based on the anatomopathological examination

07

Study locations

1 of 11 sites recruiting
  • Polyclinique Urbain V
    Avignon, France
    Not yet recruiting
  • Polyclinique Urbain V
    Avignon, France
    Not yet recruiting
  • Centre Jean Perrin
    Clermont-Ferrand, France
    • Jacques Dauplat · Contact
    Not yet recruiting
  • Groupe Hospitalier Mutualiste Clinique les Eaux Claires
    Grenoble, France
    • Philippe Gabelle · Contact
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01199354
Lead sponsor
Clinique Clementville
First posted
Sep 10, 2010
Start date
Jul 2010
Completion
Jul 2017 (estimated)
Last update
Jun 9, 2011

Study contacts

Magali Lacroix
Contact
m.lacroix@millenaire.fr
Cécile Zinzindhoue
principal investigator · Clinique Clementville
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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