EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes

NCT07593651 | Not Yet Recruiting

• 1 other identifier: EXPRESSO
• Study Type: observational
• Target: 276
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction. Within this reconstructive paradigm, surgeons may employ two distinct strategies: (i) immediate reconstruction using a direct-to-implant approach (DTI), or (ii) a two-stage reconstruction consisting of tissue expander placement followed by definitive implant insertion (TE-I). Each approach is associated with specific indications, advantages, and inherent limitations. The EXPRESSO study aims to retrospectively compare surgical outcomes between pre-pectoral DTI and TE-I breast reconstruction. By providing real-world evidence on these reconstructive strategies, this study seeks to inform surgical decision-making and to optimize reconstructive outcomes in contemporary breast cancer care.

Conditions

Breast Cancer; Operable Breast Cancer

Keywords

breast cancer; Mastectomy; Pre-pectoral reconstruction

Outcome Measures

Primary Outcomes (1)

• Primary objective

  To evaluate the rate of implant loss within 3 months per patient

  3 months post-surgery

Secondary Outcomes (1)

• Secondary objectives

  3, 12, 24 months post-surgery

Study Arms (2)

One-stage DTI

Patients who underwent one-stage direct-to-implant pre-pectoral reconstructive strategy

Two-stage TE-I

Patients who underwent two-stage expander-implant pre-pectoral reconstructive strategy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data from breast cancer patients who completed pre-pectoral implant-based breast reconstruction, both DTI and TE-I, between January 2022 and December 2024, will be retrospectively extracted from electronic medical records and institutional databases.

You may qualify if:

• Female patients ≥18 years
• Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer
• Patients undergoing pre-pectoral implant-based breast reconstruction, either:
• One-stage DTI, or
• Two-stage TE-I
• Use of implant with or without biological or synthetic mesh
• Contralateral prophylactic mastectomy allowed if a therapeutic mastectomy was performed on one side

You may not qualify if:

• Male patients
• Subpectoral implant-based reconstruction
• Autologous breast reconstruction
• Delayed reconstructions not performed at the time of mastectomy
• Incomplete clinical or follow-up data for primary endpoint analysis

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Regional Hospital Lugano (EOC), Switzerland: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Rosa Di Micco, MD, PhD

CONTACT

+39 022643; dimicco.rosa@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05