This phase III trial compares prepectoral breast reconstruction to subpectoral breast reconstruction for patients who are undergoing breast reconstruction. The prepectoral technique involves putting a tissue expander on top of the pectoralis muscle (a large muscle in the upper chest), while the subpectoral technique involves putting a tissue expander under the pectoralis muscle. The tissue expander is a temporary, balloon-like implant used to expand the breast skin and muscle before a permanent implant is placed months later through a different procedure. This study may help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach and also learn which approach causes fewer complications after surgery (for example, infection or the need for a second surgery) and which approach causes less pain and use of pain medication after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04716959.
PRIMARY OBJECTIVE:
I. Assess non-inferiority of prepectoral compared to subpectoral breast tissue expander placement with respect to short-term (0-90 days) major perioperative complications: infection, reoperation, and explantation.
SECONDARY OBJECTIVES:
I. Estimate minor complications following tissue expander (TE) placement and major complications following TE exchange to permanent implant.
II. Estimate perioperative pain, opioid use, and patient-reported outcomes following prepectoral or subpectoral tissue expander breast reconstruction and tissue expander exchange to permanent implant.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (PREPECTORAL BREAST RECONSTRUCTION): During standard of care mastectomy, patients undergo placement of TE with acellular dermal matrix (ADM) on top of the pectoralis muscle. Within 90-180 days after TE placement, patients undergo placement of a permanent saline or silicone implant.
ARM II (SUBPECTORAL BREAST RECONSTRUCTION): During standard of care mastectomy, patients undergo placement of TE under the pectoralis muscle with or without ADM. Within 90-180 days after TE placement, patients undergo placement of a permanent saline or silicone implant.
After completion of study treatment, patients are followed up at 42 and 90 days after exchange surgery.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEvan Matros
