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Breast Q for Breast Cancer

Phase 2
Waitlist Available
Led By Terence M Myckatyn, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months
Awards & highlights

Study Summary

This trial will compare the performance of two different types of acellular dermal matrices (ADM) used in post-mastectomy breast reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm Allograft Dermis has a thickness of 1.0±0.2 mm. The investigators will examine breast-reconstruction associated complication rates, pre- and post-operative patient reported outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of premature tissue expander (TE) removal
Secondary outcome measures
Amount of tissue expander fill
Comparison of direct hospital costs
Comparison of physician reimbursements
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: Cortiva 1mm Allograft DermisExperimental Treatment4 Interventions
Prior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment. On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group B will receive Cortiva 1mm Allograft Dermis A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal
Group II: Group A: Alloderm RTUExperimental Treatment4 Interventions
Prior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment. On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group A will receive Alloderm RTU A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skin or nipple-sparing mastectomy
2017
Completed Phase 2
~320
Surgery
2000
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,487 Total Patients Enrolled
46 Trials studying Breast Cancer
4,848 Patients Enrolled for Breast Cancer
RTI SurgicalIndustry Sponsor
16 Previous Clinical Trials
5,688 Total Patients Enrolled
Terence M Myckatyn, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
139 Total Patients Enrolled
1 Trials studying Breast Cancer
120 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Compare Outcomes Between Two Acellular Dermal Matrices
2017. "Compare Outcomes Between Two Acellular Dermal Matrices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02891759.
~39 spots leftby Apr 2025
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