Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella (GRATSEC)

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: fatty tissue transfer

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHU de Besancon
  • Bois-Guillaume, France, 76230
    • Clinique Saint Antoine
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Bordeaux, France, 33076
    • CHU Pellegrin
  • Chambray-Les-Tours, France, 37145
    • Pole de Sante de Leonard de Vinci
  • Créteil, France, 94010
    • Hopital Henri Mondor
  • Lyon, France, 69437
    • Hopital Edouard Herriot
  • Lyon, France, 69004
    • Centre Hospitalier La Croix Rousse
  • Marseille, France, 13273
    • Institut Paoli Calmettes
  • Marseille, France, 13005
    • CHR Marseille Conception
  • Montpellier, France, 34298
    • Centre Val d'Aurelle
  • Nantes, France, 44000
    • Clinique Brétéché
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75005
    • Institut Curie - Site Paris
  • Rennes, France, 35042
    • Centre Eugène Marquis
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Saint-Cloud, France, 92210
    • INSTITUT CURIE - René Huguenin
  • Saint-Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg
  • Toulouse, France, 31059
    • Institut Claudius Regaud
  • Toulouse, France, 31000
    • CHU Rangueil
  • Vandoeuvre-lès-Nancy, France, 54511
    • Centre Alexis Vautrin
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgery by fatty tissue transfer	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.
No Intervention: simple supervision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Investigators: Principal Investigator: Ignacio GARRIDO, MD, Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2010
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): February 21, 2017

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 17, 2009
• First Posted (Estimate): December 18, 2009

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer treated by conservative surgery
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 08 SEIN 08