Status:

UNKNOWN

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

Lead Sponsor:

Clinique Clementville

Conditions:

Breast Carcinoma

Eligibility:

FEMALE

18-75 years

Phase:

PHASE2

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 radiother...

Eligibility Criteria

Inclusion

  • 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

  • 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...

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2017

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT01199354

Start Date

July 1 2010

End Date

July 1 2017

Last Update

June 9 2011

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Polyclinique Urbain V

Avignon, France

2

Polyclinique Urbain V

Avignon, France

3

Centre Jean Perrin

Clermont-Ferrand, France

4

Groupe Hospitalier Mutualiste Clinique les Eaux Claires

Grenoble, France