Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment fatty tissue transfer
Phase phase 3
Sponsor Institut Claudius Regaud
Start date January 2010
End date August 2026
Trial size 440 participants
Trial identifier NCT01035268, 08 SEIN 08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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)

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.
time frame: 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.
time frame: 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.
time frame: 1 year

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
Principal investigator Ignacio GARRIDO, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Institut Claudius Regaud.