Study recommended for closure

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.

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.

Breast Reconstruction

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.