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

Breast Carcinoma Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01199354
• Other study ID #: CLEM-01
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2010
• Last updated: June 8, 2011
• Start date: July 2010
• Est. completion date: July 2017

Study information

• Verified date: June 2011
• Source: Clinique Clementville
• Contact: Magali Lacroix
• Email: m.lacroix[@]millenaire.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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...

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma

Intervention

Procedure:
• Mastectomy, 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Clementville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of histological remission of the surgical specimen based on the anatomopathological examination