Collecting data on pre-pectoral breast reconstruction after mastectomy for breast cancer
Official title: International Prospective REgistry on Pre-pectorAl Breast REconstruction
Run by European Breast Cancer Research Association of Surgical Trialists · NCT05817175 · Data updated 2026-11-12
This study is gathering information from women who have had mastectomies to see how well pre-pectoral breast implants work for reconstruction and how they affect quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1236 (estimated) |
| Sponsor | European Breast Cancer Research Association of Surgical Trialists Research network |
| Locations | 11 sites (Buenos Aires and 10 other locations) |
| Status | Recruiting |
| Started | September 12, 2023 |
| Main results expected | December 15, 2028 |
| Study ends | June 10, 2029 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT05817175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients over 18 years old undergoing mono or bilateral therapeutic mastectomy who consent to participate.
✕Probably not a fit
Patients who are male, unsuitable for surgical treatment, or undergoing subpectoral reconstruction will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This international multicenter observational study aims to gather data on breast reconstruction techniques using pre-pectoral implants following mastectomy for breast cancer. A total of 1,236 female patients will be enrolled, and their surgical, aesthetic, and oncological outcomes, along with quality of life, will be assessed. The study will not alter the patients' diagnostic or therapeutic paths, ensuring no additional risks are posed to participants. The data collected will help inform future patients about the best reconstruction techniques available.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve breast reconstruction options for future patients.
How similar studies have gone: Other studies have shown success with similar observational approaches in gathering data on surgical techniques, making this a valuable addition to existing knowledge.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Male patients * Patients not suitable for surgical treatment * Patients undergoing subpectoral reconstruction * Patients undergoing breast reconstruction with autologous tissue.
Where it's running
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Univesidad de Buenos Aires
Buenos Aires, Argentina Recruiting -
Mansoura Insurance
Al Mansurah, Egypt Recruiting -
Mansoura Oncology
Al Mansurah, Egypt Recruiting -
National ans Kapodistrian University of Athens
Athens, Greece Recruiting -
Ospedale San Raffaele
Milan, Mi, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Rm, Italy Recruiting
Show 5 more locations
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University Hospital of Karol Marcinkowski
Zielona Góra, Poland Recruiting -
Prof. Dr. Ion Chiricuta Institute of Oncology
Cluj-Napoca, Romania Recruiting -
Hospital del Mar
Barcelona, Spain Recruiting -
Marmara University School of medicine
Istanbul, Turkey (Türkiye) Recruiting -
University Hospitals of Leicester
Leicester, United Kingdom Recruiting
Study contacts
- Study coordinator: Oreste D Gentilini, Dr
- Email: gentilini@eubreast.com
- Phone: +390226431
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.