Breast CancerI-PREPARENCT05817175
International Prospective REgistry on Pre-pectorAl Breast REconstruction
An observational study of Breast Cancer, run by European Breast Cancer Research Association of Surgical Trialists at 11 sites in 9 countries.
Trial summary
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pre-pectoral breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 1,236 participants
- Where
- 11 sitesin 9 countries
- Study dates
- 12 Sep 2023to 10 Jun 2029
- 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: All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient. The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.
Who may be able to join
- Female patients older than 18 years old
- Signed informed consent form
- Patients undergoing mono or bilateral therapeutic mastectomy
- Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh
Who cannot join
- Male patients
- Patients not suitable for surgical treatment
- Patients undergoing subpectoral reconstruction
- Patients undergoing breast reconstruction with autologous tissue.
Trial locations and contacts
11 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 9 countries
Egypt2 sites, 2 recruiting
- Recruiting
Mansoura Insurance
Al Mansurah
Khaled Ali
- Recruiting
Mansoura Oncology
Al Mansurah
Khaled Ali, MD
Italy2 sites, 2 recruiting
- Recruiting
Ospedale San Raffaele
Milan, MI, 20132
ORESTE DAVIDE GENTILINI, MD, gentilini.oreste@hsr.it
ROSA DI MICCO
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, 00136
Gianluca Franceschini, MD
Argentina1 site, 1 recruiting
- Recruiting
Univesidad de Buenos Aires
Buenos Aires
Eduardo Gonzalez, MD
Greece1 site, 1 recruiting
- Recruiting
National ans Kapodistrian University of Athens
Athens
Michalis Kontos, MD
Poland1 site, 1 recruiting
- Recruiting
University Hospital of Karol Marcinkowski
Zielona Góra
Dawid Murawa
Romania1 site, 1 recruiting
- Recruiting
Prof. Dr. Ion Chiricuta Institute of Oncology
Cluj-Napoca
Maximilian Muntean, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona
Maria Del Mar Bernet-Tomas, MD
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of medicine
Istanbul
Umit Ugurlu, MD
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester
Leicester
Tim Rattay
About this study
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
Read the detailed description
1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.
- Conditions
- Breast Cancer
- Being tested
- pre-pectoral breast reconstruction
- Keywords
- Breast Cancer, Breast reconstruction, Pre-pectoral Breast Prosthesis, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-pectoral breast reconstructionProcedure or surgery
to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Implant-loss at three months postoperatively
Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
Measured: three months postoperatively
Secondary outcomes (5)
Number of patients with Infection
Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;
Measured: three months postoperatively
Number of patients with re-admission and re-operation
Rate of re-admission and re-operation
Measured: three months postoperatively
Evaluation of Quality of life
Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)
Measured: 0, 6, 12 and 24 months
Number of Early onset complication
Early onset complication at 3 month follow up: seroma, hematoma/bleeding, skin flap or T junction necrosis, nipple necrosis, wound dehiscence, implant malposition (i.e. rotation, displacement etc..), red-breast syndrome
Measured: three months postoperatively
Number of late-onset complications
seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;
Measured: 6-12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start12 Sep 2023
- Primary completion15 Dec 2028 (estimated)
- Study completion10 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Breast Cancer Research Association of Surgical Trialists
- Sponsor type
- Research network
- Collaborators
- EUBREAST ETS
- Responsible party
- Principal investigator, Oreste Davide Gentilini, IRCCS San Raffaele
- Investigators
- Oreste D Gentilini, Dr, Study chair, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817175
- Sponsor's protocol ID
- EUBREAST-11R
- Acronym
- I-PREPARE
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Micco R, Scardina L, Botteri E, Banys-Paluchowski M, Cardoso MJ, de Boniface J, Gasparri ML, Gulluoglu BM, Kaidar-Person O, Nava MB, Poortmans P, Potter S, Rocco N, Spanic T, Thill M, Travado L, Veselinovic K, Weber WP, Zuber V, Cisternino G, Baleri S, Rampa M, Corona SP, Calabretto F, Ceccarino R, Rottino A, Franceschini G, Kuhn T, Gentilini OD; I-PREPARE Study Group. Pre-Pectoral Breast Reconstruction after Mastectomy: Current Evidence, Knowledge Gaps, and Rationale for the I-PREPARE EUBREAST-11R Trial. Breast Care (Basel). 2026 Jun 5. doi: 10.1159/000551101. Online ahead of print.
PubMed 42383235
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective REgistry on Pre-pectorAl Breast REconstruction
- ClinicalTrials.gov ID
- NCT05817175
- Acronym / sponsor ID
- I-PREPARE / EUBREAST-11R
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast reconstruction, Pre-pectoral Breast Prosthesis, Mastectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,236 participants (estimated)
- Lead sponsor
- European Breast Cancer Research Association of Surgical TrialistsResearch network
- Collaborators
- EUBREAST ETS
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 10 Jun 2029 (estimated)
- First posted
- 18 Apr 2023 (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.
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
Detailed description
1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient. The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.
Key inclusion criteria (4 listed)
- Female patients older than 18 years old
- Signed informed consent form
- Patients undergoing mono or bilateral therapeutic mastectomy
- Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh
Key exclusion criteria (4 listed)
- Male patients
- Patients not suitable for surgical treatment
- Patients undergoing subpectoral reconstruction
- Patients undergoing breast reconstruction with autologous tissue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-pectoral breast reconstructionto prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy | Procedure or surgery | – |
Primary outcome
Number of patients with Implant-loss at three months postoperatively
Time frame: three months postoperatively
Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
5 secondary outcomes
Number of patients with Infection
Time frame: three months postoperatively
Number of patients with re-admission and re-operation
Time frame: three months postoperatively
Evaluation of Quality of life
Time frame: 0, 6, 12 and 24 months
Number of Early onset complication
Time frame: three months postoperatively
Number of late-onset complications
Time frame: 6-12-24 months
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 11 Sep 2026.
- Derived from this study: PubMed 42383235Di Micco R, Scardina L, Botteri E, Banys-Paluchowski M, Cardoso MJ, de Boniface J, Gasparri ML, Gulluoglu BM, Kaidar-Person O, Nava MB, Poortmans P, Potter S, Rocco N, Spanic T, Thill M, Travado L, Veselinovic K, Weber WP, Zuber V, Cisternino G, Baleri S, Rampa M, Corona SP, Calabretto F, Ceccarino R, Rottino A, Franceschini G, Kuhn T, Gentilini OD; I-PREPARE Study Group. Pre-Pectoral Breast Reconstruction after Mastectomy: Current Evidence, Knowledge Gaps, and Rationale for the I-PREPARE EUBREAST-11R Trial. Breast Care (Basel). 2026 Jun 5. doi: 10.1159/000551101. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Oreste D Gentilini, Dr study chair
IRCCS San Raffaele
11 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Breast Cancer Research Association of Surgical Trialists at 11 sites in 9 countries.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Egypt, Italy, Argentina, Greece, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Oreste D Gentilini, Dr (+390226431 ext. 3939, gentilini@eubreast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Implant-loss at three months postoperatively (time frame: three months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817175, which also lists 1 linked publication.
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 11 Sep 2026.