Clinical trial NCT01035268: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
Official title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer treated by conservative surgery
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Bois-Guillaume
country: France
facility: Clinique Saint Antoine
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Bordeaux
country: France
facility: Institut Bergonie
city: Chambray-Les-Tours
country: France
facility: Pole de Sante de Leonard de Vinci
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Lyon
country: France
facility: Centre Hospitalier La Croix Rousse
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: CHR Marseille Conception
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Nantes
country: France
facility: Clinique Brétéché
city: Paris
country: France
facility: INSTITUT CURIE - Site Paris
city: Paris
country: France
facility: Hopital Saint Louis
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: INSTITUT CURIE - René Huguenin
city: Saint-Herblain
country: France
facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU Rangueil
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre-lès-Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Claudius Regaud
name: Ignacio GARRIDO, MD
role: PRINCIPAL_INVESTIGATOR
References: