NCT01035268

Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2010-02-08
• Primary completion: 2015-10-01
• Completion: 2017-02-21
• First posted: 2009-12-18
• Last updated: 2018-08-22

Locations

23 sites across 1 country: France