Breast CancerEXPRESSONCT07593651
EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes
An observational study of Breast Cancer and Operable Breast Cancer, run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Operable Breast Cancer
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes : the EXPRESsO Study
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).
Read more
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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
To evaluate the rate of implant loss within 3 months per patient
Measured: 3 months post-surgery
Secondary outcomes (1)
Secondary objectives
To evalueate early and late-onset postoperative complications and to revaluate re-admission and re-operation rates
Measured: 3, 12, 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Hospital Lugano (EOC), Switzerland
- Responsible party
- Principal investigator, Rosa Di Micco, MD, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593651
- Sponsor's protocol ID
- EXPRESSO
- Acronym
- EXPRESSO
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes : the EXPRESsO Study
- ClinicalTrials.gov ID
- NCT07593651
- Acronym / sponsor ID
- EXPRESSO / EXPRESSO
- Conditions
- Breast Cancer, Operable Breast Cancer
- Keywords
- breast cancer, Mastectomy, Pre-pectoral reconstruction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Regional Hospital Lugano (EOC), Switzerland
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 May 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Female patients ≥18 years
- Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer
- Patients undergoing pre-pectoral implant-based breast reconstruction, either:
- Use of implant with or without biological or synthetic mesh
- Contralateral prophylactic mastectomy allowed if a therapeutic mastectomy was performed on one side
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary objective
Time frame: 3 months post-surgery
To evaluate the rate of implant loss within 3 months per patient
1 secondary outcome
Secondary objectives
Time frame: 3, 12, 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Operable Breast Cancer, run by IRCCS San Raffaele.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa Di Micco, MD, PhD (+39 022643 ext. 4565, dimicco.rosa@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: 3 months post-surgery). 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 18 May 2026.