Breast Cancer
Conditions
Keywords
breast cancer treated by conservative surgery
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.
Interventions
PROCEDUREfatty 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.
Sponsors
Institut Claudius Regaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
France
Outcome results
None listed