Clinical trial NCT01910298: Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
Official title: A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mastectomy and Breast Reconstruction
Keywords: Breast reconstruction
Breast implant
Breast cancer
Mastectomy
Lead sponsor: LifeCell
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this study is to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander will be exchanged for a breast implant only, without any type of a reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy.

Two-stage breast reconstruction will include the initial placement of a tissue expander in a total or partial submuscular position. In the case of partial muscle coverage, this will be without the support of any mesh or autologous flap to reinforce the lower pole. The expander will be inflated over approximately the next one to six months, and then replaced with an implant.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 3rd 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
* Any of the conditions identified within the labelled contraindications, i.e. sensitivity to porcine derived products or polysorbate 20.

Primary outcomes:
measure: 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)
timeFrame: Up to 12 months post ISS
Secondary outcomes:
measure: Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)
timeFrame: Up to 12 months post ISS
measure: Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)
timeFrame: Up to 24 months ppR
measure: Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR
timeFrame: Up to 24 months ppR
measure: Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel
timeFrame: Baseline up to Month 24
measure: Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS
timeFrame: Baseline up to 6 months post ISS
measure: Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast
timeFrame: Within 24 months ppR
Other outcomes:
measure: Health-related Quality of Life
timeFrame: At 3, 6, and 12 months post-mastectomy and at 4 months ppR
measure: Healthcare Resource Use Including Length of Hospital Stay and Clinic Visits
timeFrame: At 6 and 12 months post-mastectomy and at 24 months ppR
measure: Time to Return to Work or Normal Daily Activities
timeFrame: 6 and 12 months post-mastectomy and 24 month ppR
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lille Cedex
country: France
facility: Centre Oscar Lambret
city: Montpellier Cedex 5
country: France
facility: Institut du Cancer de Montpellier Val d'Aurelle
city: Paris
country: France
facility: L'Institut du Sein- Paris Breast Center
city: Paris
country: France
facility: Hopital Tenon APHP
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitäts-Frauenklinik Heidelberg
city: Munich
country: Germany
facility: Klinik der Universität München, Campus Innenstadt
city: Munich
country: Germany
facility: Klinikum rechts der Isar
city: Wiesbaden
country: Germany
facility: Asklepios Paulinen Klinik
city: Bradford
country: United Kingdom
facility: St Luke's hospital / Bradford Royal Infirmary (BRI)
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital UHSM NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: City Hospital
Study officials:
affiliation: Allergan
name: Donna Jacobs
role: STUDY_CHAIR
References: