Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

Breast Cancer Clinical Trial

— GRATSEC  

Official title:

Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01035268
• Other study ID #: 08 SEIN 08
• Status: Terminated
• Phase: Phase 3
• Start date: February 8, 2010
• Est. completion date: February 21, 2017

Study information

• Verified date: August 2018
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.

It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.

follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse.

During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 196
• Est. completion date: February 21, 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of breast cancer treated by conservative surgery .

• Normal inclusion radiological assessment normal (ACR1 or ACR2)

• Moderate Deformations (Type I and II of the classification of Clough).

• Delay with regard to the end of the radiotherapy superior or equal to one-year-old.

• Moderated radio-dystrophies (< Grade 2 of the score LENT/SOMA).

• Signature of the informed consent

• Patient benefiting from social security

• Patient of more than 18 years old

Exclusion Criteria:

• Abnormal radiological assessment (ACR3, ACR4 or ACR5)

• Absence of fatty excess .

• radio surgical relapses with vast fibroses of the breast (> Grade 2 of the score LENT/SOMA).

• Patient under 18 years old.

• administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent .

• pregnant women or breast feeding women

• patient under legal guardianship

• bilateral breast cancer regardless histologic type.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• fatty tissue transfer
It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Clinique Saint Antoine	Bois-Guillaume
France	CHU Pellegrin	Bordeaux
France	Institut Bergonie	Bordeaux
France	Pole de Sante de Leonard de Vinci	Chambray-Les-Tours
France	Hopital Henri Mondor	Créteil
France	Centre Hospitalier La Croix Rousse	Lyon
France	Hopital Edouard Herriot	Lyon
France	CHR Marseille Conception	Marseille
France	Institut Paoli Calmettes	Marseille
France	Centre Val d'Aurelle	Montpellier
France	Clinique Brétéché	Nantes
France	Hopital Saint Louis	Paris
France	INSTITUT CURIE - Site Paris	Paris
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	INSTITUT CURIE - René Huguenin	Saint-Cloud
France	INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau	Saint-Herblain
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	CHU Rangueil	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre-lès-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.		1 year
Secondary	Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.		1 year
Secondary	Estimate the technique on the carcinological plan : Estimate the rate of local relapse and\or in distance. Estimate the rate of survival of the patients.		1 year