Comparing Two Different Surgical Techniques for Breast Reconstruction

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Reconstruction
• Intervention / Treatment: Procedure: Prepectoral Prosthetic Breast Reconstruction; Procedure: Subpectoral Prosthetic Breast Reconstruction

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering BaskingRidge (Consent and Followup)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Consent and Followup)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent and Followup )
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Consent and Followup)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent and Followup)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    • Rockville Centre, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Consent and Followup)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prepectoral Prosthetic Breast Reconstruction	Procedure: Prepectoral Prosthetic Breast Reconstruction; The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
ACTIVE_COMPARATOR: Subpectoral Prosthetic Breast Reconstruction	Procedure: Subpectoral Prosthetic Breast Reconstruction; The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
minor complications	Minor complication for tissue expanders is defined as: Seroma: clinically significant non-infected fluid collection requiring either needle aspiration or drain replacement	90 days

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Evan Matros, MD, MMSc, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ACTUAL): December 13, 2021
• Study Completion (ACTUAL): December 13, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (ACTUAL): January 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Prosthetic; Breast tissue expander; 20-565
• Other Study ID Numbers: 20-565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No