Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella (GRATSEC)

Institut Claudius Regaud

Status and phase

Terminated

Phase 3

Conditions

Breast Cancer

Treatments

Procedure: fatty tissue transfer

Study type

Interventional

Funder types

Other

Identifiers

NCT01035268

08 SEIN 08

Details and patient eligibility

About

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.

Enrollment

196 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.