Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy

NCT01910298 | Terminated Results DMC

• 1 other identifier: LFC 2012.06.01
• Study Type: interventional
• Target: 131
• Locations: 3 countries
• Sites: 18

Brief Summary

The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.

Conditions

Mastectomy and Breast Reconstruction

Keywords

Breast reconstruction; Breast implant; Breast cancer; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS)

  ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.

  Up to 12 months post ISS

Secondary Outcomes (6)

• Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)

  Up to 12 months post ISS

• Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)

  Up to 24 months ppR

• Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR

  Up to 24 months ppR

• Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel

  Baseline up to Month 24

• Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS

  Baseline up to 6 months post ISS

Other Outcomes (3)

• Health-related Quality of Life

  At 3, 6, and 12 months post-mastectomy and at 4 months ppR

• Healthcare Resource Use Including Length of Hospital Stay and Clinic Visits

  At 6 and 12 months post-mastectomy and at 24 months ppR

• Time to Return to Work or Normal Daily Activities

  6 and 12 months post-mastectomy and 24 month ppR

Study Arms (2)

Breast Reconstruction, Direct to Implant (DTI) with Strattice™

ACTIVE COMPARATOR

Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).

Procedure: Breast Reconstruction, Direct to Implant (DTI) with Strattice™

Two Stage Breast Reconstruction

ACTIVE COMPARATOR

Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.

Procedure: Two Stage Breast Reconstruction

Interventions

Breast Reconstruction, Direct to Implant (DTI) with Strattice™ PROCEDURE

Breast Reconstruction, Direct to Implant (DTI) with Strattice™

Two Stage Breast Reconstruction PROCEDURE

Two Stage Breast Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Single Stage Breast Reconstruction in Female Participants with Mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female 18 years or older
• A candidate for both arms of the study involving immediate breast reconstruction post-skin sparing mastectomy (unilateral or bilateral) DTI with the use of Strattice™ Reconstructive Tissue Matrix (TM), 2 stage with use of Tissue Expander through exchange to Implant without support of a mesh or autologous tissue)
• An American Society of Anesthesiologists (ASA) Physical Status Classification of 1 or 2
• Estimated life expectancy \> 3 years
• Able and willing to return for all scheduled and required study visits
• Able to provide written informed consent for study participation

You may not qualify if:

• Clinically significant systemic disease, as determined by the Investigator, which could affect study participation or study results
• Received neo-adjuvant, inductive chemo-therapy (except Herceptin, or other targeted therapy) within 4 weeks prior to mastectomy
• Previous radiation therapy to either breast at any time
• Predicted permanent implant size that is greater than or equal to 500 grams (gms), per Investigator assessment
• Body mass index (BMI) \<17 or \> 30
• Co-morbid factors which predispose to postoperative infection, e.g. diabetes, collagen vascular disease, chronic steroid (except inhalers)/immunosuppressant use, immune deficiency, or co-existent infection
• Pregnant or lactating
• rd degree ptosis
• Prior breast surgery including breast reduction, augmentation, mastopexy, quadrectomy, and partial mastectomy with reduction of the skin envelope
• Prior use of a device (mesh or matrix) in the Breast
• Concomitant unrelated condition of breast/chest wall/skin that, as determined by the investigator, could adversely affect the surgical outcome (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
• Planned autologous tissue flap in addition to prosthetic implant
• Use of permanent expander implants such as Becker expanders or the Natrelle™ Permanent expander 150
• Current alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
• Currently enrolled or plans to enroll in another clinical trial unless it is: a registry, a retrospective study, a neo-adjuvant chemotherapy trial (as long as the chemotherapy regimen has been stopped 4 weeks prior to mastectomy), or a hormone/anti-hormonal therapy trial

Sponsors & Collaborators

• LifeCell: lead

Study Sites (18)

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Institut du Cancer de Montpellier Val d'Aurelle

Montpellier, 34298, France

Location

L'Institut du Sein- Paris Breast Center

Paris, 75116, France

Location

Hopital Tenon APHP

Paris, France

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Kliniken Essen-Mitte

Essen, 45131, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitäts-Frauenklinik Heidelberg

Heidelberg, 69115, Germany

Location

Klinik der Universität München, Campus Innenstadt

Munich, 80337, Germany

Location

Klinikum rechts der Isar

Munich, 81675, Germany

Location

Asklepios Paulinen Klinik

Wiesbaden, 65197, Germany

Location

St Luke's hospital / Bradford Royal Infirmary (BRI)

Bradford, BD5 0NA, United Kingdom

Location

Dorset County Hospital

Dorchester, DT1 2JY, United Kingdom

Location

Frimley Park Hospital

Frimley, GU16 7UJ, United Kingdom

Location

Wythenshawe Hospital UHSM NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty; Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Donna Jacobs

  Allergan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 29, 2013
• Study Start: July 29, 2013
• Primary Completion: August 31, 2016
• Study Completion: October 23, 2017
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-04

Locations

FR (5); GB (5); DE (8)