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

I

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

196 participants in 2 patient groups

surgery by fatty tissue transfer
Experimental group
Treatment:
Procedure: fatty tissue transfer
simple supervision
No Intervention group

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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