NCT05125991

Brief Summary

The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 24, 2023

Status Verified

June 1, 2023

Enrollment Period

4.8 years

First QC Date

October 25, 2021

Last Update Submit

August 23, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Satisfaction assessed by the BREAST-Q

    The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

    1 year

Secondary Outcomes (4)

  • Immediate complications rate

    1 month

  • Short term complications rate

    6 months

  • Long term complications rate

    24 months

  • Percentage of capsular contracture

    1 year

Study Arms (2)

Prepectoral reconstruction

EXPERIMENTAL

Prepectoral breast reconstruction with Braxon dermal matrix

Procedure: Prepectoral reconstruction

Submuscular reconstruction

ACTIVE COMPARATOR

Submuscolar breast reconstruction

Procedure: Submuscolar reconstruction

Interventions

Prepectoral reconstructionPROCEDURE

Prepectoral breast reconstruction

Prepectoral reconstruction
Submuscolar reconstructionPROCEDURE

Submuscolar breast reconstruction

Submuscular reconstruction

Eligibility Criteria

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

You may qualify if:

  • Informed consent
  • Not smokers
  • No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
  • BMI\<30
  • CUP B-C (or mastectomy estimated weight less than 550gm)
  • Good subcutaneous layer (\>1cm on pinch test measured in upper/medial quadrant)
  • No previous breast surgery
  • No previous breast irradiation
  • Breast Ptosis 1-2 according to Renault's classification
  • DCIS tumors
  • T1 T2 pN0 breast tumor with known favourable biologic features

You may not qualify if:

  • Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
  • Positive sentinel node biopsy requiring complete axillary dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Francesca De Lorenzi, PhD, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

  • Paolo Veronesi, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 18, 2021

Study Start

September 3, 2019

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

August 24, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)