Breast ReconstructionPhase 3NCT04716959
Comparing Two Different Surgical Techniques for Breast Reconstruction
A Phase 3 study testing Prepectoral Prosthetic Breast Reconstruction and Subpectoral Prosthetic Breast Reconstruction in people with Breast Reconstruction, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander… Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Prepectoral Prosthetic Breast Reconstruction and Subpectoral Prosthetic Breast Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Jan 2021to 13 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 21-60 years
- Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.
- Planning to undergo unilateral or bilateral mastectomy.
- Planning to undergo nipple- or skin-sparing mastectomy.
- Mastectomy weight less than 800 grams.
- Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion.
Who cannot join
- Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.
- Presence of preoperative axillary lymph node metastasis.
- Presence of intraoperative sentinel node positivity.
- History of radiotherapy.
- Current smoker.
- Planning to undergo direct-to-implant reconstruction.
- BMI >35.
- Prior sternotomy.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering BaskingRidge (Consent and Followup)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent and Followup)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and Followup)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and Followup)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Followup )
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and Followup)
Rockville Centre, New York, 11553
About this study
Official title: A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction
The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle.
The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.
- Conditions
- Breast Reconstruction
- Being tested
- Prepectoral Prosthetic Breast Reconstruction, Subpectoral Prosthetic Breast Reconstruction
- Keywords
- Prosthetic, Breast tissue expander, 20-565
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepectoral Prosthetic Breast ReconstructionProcedure or surgery
The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
Subpectoral Prosthetic Breast ReconstructionProcedure or surgery
The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).
| Study group | Role | What they receive |
|---|---|---|
| Prepectoral Prosthetic Breast Reconstruction | Experimental | Not described Receives: Procedure: Prepectoral Prosthetic Breast Reconstruction |
| Subpectoral Prosthetic Breast Reconstruction | Active comparator | Not described Receives: Procedure: Subpectoral Prosthetic Breast Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
major perioperative complications
90-day major complications for tissue expanders (i.e., infection, explantation, and reoperation for mastectomy flap necrosis):
- Infection: any event requiring restart of antibiotics (oral or intravenous) following completion of initial perioperative antibiotics or an admission to the hospital for cellulitis.
- Explantation: need for tissue expander removal for any cause.
- Reoperation: skin excision performed in either the clinic or the main operating room for mastectomy skin flap necrosis.
Measured: 90 days
Secondary outcomes (1)
minor complications
Minor complication for tissue expanders is defined as: Seroma: clinically significant non-infected 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 posted20 Jan 2021
- Study start14 Jan 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Why it stopped: Study recommended for closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Matros, MD, MMSc, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716959
- Sponsor's protocol ID
- 20-565
- Status last verified
- Dec 2021
- First submitted
- 19 Jan 2021
- Last updated
- 3 Jan 2022
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04716959
- Acronym / sponsor ID
- 20-565
- Conditions
- Breast Reconstruction
- Keywords
- Prosthetic, Breast tissue expander, 20-565
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study recommended for closure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 20 Jan 2021 (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 purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle.
The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prepectoral Prosthetic Breast Reconstruction | Experimental | Procedure: Prepectoral Prosthetic Breast Reconstruction |
| Subpectoral Prosthetic Breast Reconstruction | Active comparator | Procedure: Subpectoral Prosthetic Breast Reconstruction |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 21-60 years
- Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.
- Planning to undergo unilateral or bilateral mastectomy.
- Planning to undergo nipple- or skin-sparing mastectomy.
- Mastectomy weight less than 800 grams.
Key exclusion criteria (8 listed)
- Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.
- Presence of preoperative axillary lymph node metastasis.
- Presence of intraoperative sentinel node positivity.
- History of radiotherapy.
- Current smoker.
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 Prosthetic Breast ReconstructionThe prepectoral approach involves placing the tissue expander on top of the pectoralis muscle. | Procedure or surgery | Prepectoral Prosthetic Breast Reconstruction |
| Subpectoral Prosthetic Breast ReconstructionThe subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM). | Procedure or surgery | Subpectoral Prosthetic Breast Reconstruction |
Primary outcome
major perioperative complications
Time frame: 90 days
90-day major complications for tissue expanders (i.e., infection, explantation, and reoperation for mastectomy flap necrosis): * Infection: any event requiring restart of antibiotics (oral or intravenous) following completion of initial perioperative antibiotics or an admission to the hospital for cellulitis. * Explantation: need for tissue expander removal for any cause. * Reoperation: skin excision performed in either the clinic or the main operating room for mastectomy skin flap necrosis.
1 secondary outcome
minor complications
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- 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, MMSc, MPH principal investigator
Memorial Sloan Kettering Cancer Center
7 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 Prosthetic Breast Reconstruction and Subpectoral Prosthetic Breast Reconstruction in people with Breast Reconstruction, run by Memorial Sloan Kettering Cancer Center at 7 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 8 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: withdrawn, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
major perioperative 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?
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 3 Jan 2022; AzTrials last refreshed its copy on 28 Oct 2026.