Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

Phase 3

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01035268
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Study Start: 2010-02-08
• Primary Completion: 2015-10
• Study Completion: 2017-02-21
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (23)

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

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