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New study tests whether extra material in breast reconstruction is worth it

NCT ID NCT05316324

Symptom relief Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two methods of prepectoral breast reconstruction after mastectomy for breast cancer: one using acellular dermal matrix (ADM) and one without. The goal is to see if using ADM leads to fewer major complications like infection or implant removal within 90 days. About 353 women aged 21-60 are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acellular dermal matrix (ADM)
What this could lead to
If successful, this study could show that using ADM in breast reconstruction does not reduce complications, potentially simplifying the procedure and reducing costs.
What could go wrong
This is a single-center trial, and results may not apply to all patients or surgical techniques. The study only looks at short-term complications, not long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

353 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Females aged 21-60 years * Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer * Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage * Planning to undergo nipple-sparing or skin-sparing mastectomy * 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 * Intraoperative confirmation of prepectoral plane viability by operating physician Exclusion Criteria: * History of radiotherapy to the operative breast * Current smoker * Non-English speaking patients * Planning to undergo direct-to-implant reconstruction * Prior sternotomy

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Rockville Centre, New York, 11553, United States

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