NCT00616135

Brief Summary

A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2008

Typical duration for phase_4

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

2.4 years

First QC Date

February 5, 2008

Last Update Submit

May 13, 2011

Conditions

Breast NeoplasmsCarcinoma, Ductal, BreastMammaplastyMastectomy, Segmental, Lumpectomy, Breast Reconstruction,

Keywords

BreastStem CellAdipose Derived Stem CellsAdipose Derived Regenerative CellsADRCReconstructive Breast SurgeryBreast ReconstructionCancerCarcinomaAutologous fat transplantationAutologous fatCosmetic breast deformitiesFunctional breast deformityLumpectomySegmental mastectomyQuadrantectomybreast conservation therapy

Outcome Measures

Primary Outcomes (1)

  • Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.

    12 months

Secondary Outcomes (1)

  • Change in breast volume and shape at 6 and 12 Months compared to baseline. Improvement in skin pigmentation abnormalities at 6 and 12 months compared to Baseline. Improvement in overall breast deformity at 6 Months compared to Baseline.

    6 months and 12 months

Interventions

ADRC-Enhanced Autologous Fat TransplantPROCEDURE

Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
  • Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
  • Clean surgical margins
  • No prosthesis in breast(s) to undergo treatment
  • Ability to undergo lipoaspiration
  • Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
  • No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
  • Objective signs of mild breast damage post Breast Conservation Therapy
  • Type I Cosmetic Sequelae Classification
  • A minimum of 1 cm of soft tissue (e.g. breast or fat) is available between the skin and chest wall at the recipient site
  • A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
  • No continuous adhesion of skin to bone \>3 cm in diameter
  • The volume and shape of the defect(s) must be conducive to correction during a single treatment session (maximum defect volume ≤150 mL in breast(s) to undergo treatment)

You may not qualify if:

  • History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
  • History of connective, metabolic or atrophic skin disease
  • History of keloid scarring
  • Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
  • Life expectancy ≤ 2 years
  • Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment
  • Presence of any other known malignancy
  • Body Mass Index (BMI) \>30
  • Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI \>5 compared to baseline
  • Presence of contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Jules Bordet Institute of Cancer

Brussels, Belgium

Location

Università degli Studi di Firenze

Florence, 50134, Italy

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Instituto Valenciano Oncologia

Valencia, 46009, Spain

Location

Glasgow Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Ductal, BreastNeoplasmsCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, DuctalAdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

May 17, 2011

Record last verified: 2011-05

Locations

ES(2)BE(1)GB(1)IT(1)