Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: fatty tissue transfer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery by fatty tissue transfer<br> | Procedure: fatty tissue transfer<br>* 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.<br>|
| No Intervention: simple supervision<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer treated by conservative surgery