Breast CancerPhase 3NCT05316324
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
A Phase 3 study testing Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) and Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) and Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2022to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of radiotherapy to the operative breast
- Current smoker
- Non-English speaking patients
- Planning to undergo direct-to-implant reconstruction
- Prior sternotomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
About this study
Official title: A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
- Conditions
- Breast Cancer
- Being tested
- Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM), Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
- Keywords
- Acellular Dermal Matrix, Breast Reconstruction, Mastectomy, 22-071
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)Procedure or surgery
Prepectoral Breast Reconstruction with (ADM)
Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)Procedure or surgery
Prepectoral Breast Reconstruction without ADM
| Study group | Role | What they receive |
|---|---|---|
| Prepectoral Breast Reconstruction with ADM | Experimental | Not described Receives: Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) |
| Prepectoral Breast Reconstruction without ADM | Experimental | Not described Receives: Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who experience major complications
Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis):
- Infection defined as:
- Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics
- Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics
- Purulent drainage from the surgical site or incision
- Explantation defined as the need for removal of a TE for any cause
- Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication
Measured: 90 days
Secondary outcomes (1)
Estimate rates of minor complications (specifically seroma)
Minor complication for (Tissue Expanders) TEs are defined as:
- Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start23 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Plastic Surgery Foundation
- Responsible party
- Sponsor
- Investigators
- Evan Matros, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316324
- Sponsor's protocol ID
- 22-071
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Nelson JA, Shammas RL, Boe LA, Gonen M, Poulton RT, Stern CS, Rochlin DH, McCarthy CM, Allen RJ Jr, Coriddi M, Disa JJ, Mehrara BJ, Matros E. Two-Stage Prepectoral Breast Reconstruction with and without Acellular Dermal Matrix: A Cluster-Randomized Noninferiority Trial. Plast Reconstr Surg. 2026 Mar 11. doi: 10.1097/PRS.0000000000013019. Online ahead of print.
PubMed 41811168
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix
- ClinicalTrials.gov ID
- NCT05316324
- Acronym / sponsor ID
- 22-071
- Conditions
- Breast Cancer
- Keywords
- Acellular Dermal Matrix, Breast Reconstruction, Mastectomy, 22-071
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- The Plastic Surgery Foundation
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prepectoral Breast Reconstruction with ADM | Experimental | Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) |
| Prepectoral Breast Reconstruction without ADM | Experimental | Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- History of radiotherapy to the operative breast
- Current smoker
- Non-English speaking patients
- Planning to undergo direct-to-implant reconstruction
- Prior sternotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)Prepectoral Breast Reconstruction with (ADM) | Procedure or surgery | Prepectoral Breast Reconstruction with ADM |
| Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)Prepectoral Breast Reconstruction without ADM | Procedure or surgery | Prepectoral Breast Reconstruction without ADM |
Primary outcome
Percentage of patients who experience major complications
Time frame: 90 days
Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): * Infection defined as: * Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics * Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics * Purulent drainage from the surgical site or incision * Explantation defined as the need for removal of a TE for any cause * Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication
1 secondary outcome
Estimate rates of minor complications (specifically seroma)
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 41811168Nelson JA, Shammas RL, Boe LA, Gonen M, Poulton RT, Stern CS, Rochlin DH, McCarthy CM, Allen RJ Jr, Coriddi M, Disa JJ, Mehrara BJ, Matros E. Two-Stage Prepectoral Breast Reconstruction with and without Acellular Dermal Matrix: A Cluster-Randomized Noninferiority Trial. Plast Reconstr Surg. 2026 Mar 11. doi: 10.1097/PRS.0000000000013019. Online ahead of print.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Matros, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) and Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who experience major complications (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05316324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.