Collecting data on pre-pectoral breast reconstruction after mastectomy for breast cancer
International Prospective REgistry on Pre-pectorAl Breast REconstruction
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 |
|---|---|
| Enrollment | 1236 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 11 sites (Buenos Aires and 10 other locations) |
| Trial ID | NCT05817175 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients over 18 years old undergoing mono or bilateral therapeutic mastectomy who consent to participate.
Not a fit: Patients who are male, unsuitable for surgical treatment, or undergoing subpectoral reconstruction will not benefit from this study.
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 performed: Other studies have shown success with similar observational approaches in gathering data on surgical techniques, making this a valuable addition to existing knowledge.
Eligibility criteria
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 this trial is running
Buenos Aires and 10 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.