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Acellular Dermal Matrix in Breast Reconstruction Post-Cancer

Phase 3
Recruiting
Led By Evan Matros, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
Must not have
Non-English speaking patients
Planning to undergo direct-to-implant reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying whether using a special material in breast reconstruction reduces problems like infections and the need for more surgeries. This material helps support new tissue growth. The goal is to see if patients have fewer issues after surgery when this material is used. This material has been increasingly used in breast reconstruction surgeries to support tissue growth and improve how the breast looks, though its impact on problems remains debated.

Who is the study for?
This trial is for women aged 21-60 who are planning nipple-sparing or skin-sparing mastectomies, either as a preventive measure or to treat breast cancer. They must be able to undergo immediate two-stage prosthetic breast reconstruction with tissue expander placement first. Women can't join if they've had chest radiation, currently smoke, don't speak English, or plan direct-to-implant reconstruction.
What is being tested?
The study compares the outcomes of prepectoral breast reconstruction using Acellular Dermal Matrix (ADM) versus without ADM. It focuses on immediate postoperative complications like infections and issues that might require additional surgery or removal of implants.
What are the potential side effects?
Potential side effects may include infection risks at the surgical site, possible reactions to the Acellular Dermal Matrix material used in some patients, and complications leading to further surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I plan to have a two-stage breast reconstruction with an initial tissue expander.
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The skin around my mastectomy area has good blood flow or can be treated by removing a small part.
Select...
I plan to have a mastectomy that preserves the nipple or skin.
Select...
My surgeon confirmed the area in front of my chest muscles is suitable for surgery.
Select...
I am a woman aged between 21 and 60.
Select...
I am planning to have one or both breasts removed as a preventive measure or to treat breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not speak English.
Select...
I plan to have breast implants immediately after mastectomy.
Select...
I have had open-heart surgery before.
Select...
I have had radiation therapy on the breast where surgery was performed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients who experience major complications
Secondary study objectives
Estimate rates of minor complications (specifically seroma)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prepectoral Breast Reconstruction without ADMExperimental Treatment1 Intervention
Group II: Prepectoral Breast Reconstruction with ADMExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Breast cancer treatments typically include surgery to remove the tumor, chemotherapy to kill cancer cells, radiation therapy to destroy remaining cancerous tissue, hormone therapy to block hormones that fuel certain cancers, and targeted therapy to attack specific cancer cell mechanisms. The use of Acellular Dermal Matrix (ADM) in breast reconstruction post-mastectomy provides a scaffold for tissue integration, potentially reducing complications such as infections and the need for additional surgeries. This is crucial for breast cancer patients as it can improve surgical outcomes, enhance recovery, and reduce the physical and emotional burden of multiple procedures.
Sarcoma of the breast: an update on a rare entity.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,965 Previous Clinical Trials
596,631 Total Patients Enrolled
205 Trials studying Breast Cancer
81,943 Patients Enrolled for Breast Cancer
The Plastic Surgery FoundationOTHER
9 Previous Clinical Trials
885 Total Patients Enrolled
1 Trials studying Breast Cancer
200 Patients Enrolled for Breast Cancer
Evan Matros, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05316324 — Phase 3
Breast Cancer Research Study Groups: Prepectoral Breast Reconstruction with ADM, Prepectoral Breast Reconstruction without ADM
Breast Cancer Clinical Trial 2023: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) Highlights & Side Effects. Trial Name: NCT05316324 — Phase 3
Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05316324 — Phase 3
~112 spots leftby Mar 2026