NCT02055937

Brief Summary

The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

October 9, 2013

Last Update Submit

August 7, 2020

Conditions

Breast Cancer

Keywords

mastectomy, reconstruction

Outcome Measures

Primary Outcomes (1)

  • Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.

    Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. Significant complication is defined as: * Any event delaying RT (delay surgery/RT \> 3 months) * Any event preventing patients from receiving radiotherapy within 6 months after surgery

    confirm the feasibility of the therapeutic sequence at 6 months

Secondary Outcomes (1)

  • The rate of Baker

    up to 36 months after surgery

Other Outcomes (4)

  • Cosmetic results

    up to 36 months after surgery

  • Functional results

    up to 36 months after surgery

  • The rate of patients requiring breast implant removal

    up to 36 months after surgery

  • +1 more other outcomes

Study Arms (1)

immediate implant breast reconstruction

EXPERIMENTAL

immediate implant breast reconstruction

Procedure: immediate implant breast reconstruction

Interventions

immediate implant breast reconstructionPROCEDURE

Eligible patients will undergo radical mastectomy with axillary lymph nodes sampling followed by immediate and single-stage breast reconstruction using the acellular dermal matrix Strattice™

immediate implant breast reconstruction

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed breast carcinoma
  • Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation)
  • Patients planned to receive postoperative chest wall irradiation
  • Age ≥ 18 years old
  • WHO performance status 0-1
  • Affiliation to a social security system
  • Informed consent signed prior any study specific procedures

You may not qualify if:

  • Inflammatory breast cancer
  • Tumors with extensive involvement of the skin
  • Use of tissue expander
  • Indication of postoperative chemotherapy
  • Patients planned for bilateral mastectomy
  • History of previously treated ipsilateral breast carcinoma
  • Usual contraindications for ADM
  • Medical debility precluding surgical treatment
  • Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
  • Pregnancy or breast feeding
  • Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
  • Legal inability or restricted legal ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut régional du Cancer - Montpellier - Val d'Aurelle

Montpellier, 34000, France

Location

Related Publications (2)

  • Christian CK, Niland J, Edge SB, Ottesen RA, Hughes ME, Theriault R, Wilson J, Hergrueter CA, Weeks JC. A multi-institutional analysis of the socioeconomic determinants of breast reconstruction: a study of the National Comprehensive Cancer Network. Ann Surg. 2006 Feb;243(2):241-9. doi: 10.1097/01.sla.0000197738.63512.23.

    PMID: 16432358BACKGROUND

  • Lambert K, Mokbel K. Does post-mastectomy radiotherapy represent a contraindication to skin-sparing mastectomy and immediate reconstruction: an update. Surg Oncol. 2012 Jun;21(2):e67-74. doi: 10.1016/j.suronc.2011.12.007. Epub 2012 Jan 30.

    PMID: 22296996BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

February 5, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

May 30, 2018

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

FR(1)