At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- pre-pectoral breast reconstruction (procedure)
- How long the study runs
- Study runs about 69 months (dates as stated)
- About the drug or intervention
- pre-pectoral breast reconstruction — procedure: 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
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 1,236
- Started
- 2023-09-12
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Clinical study - 1,236 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
- • Female only
Where?
- • Leicester - University Hospitals of Leicester
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Female patients older than 18 years old
- ✓Signed agreement to take part 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 take part
- ✗Male patients
- ✗Patients not suitable for surgical treatment
- ✗Patients undergoing subpectoral reconstruction
- ✗Patients undergoing breast reconstruction with autologous tissue.
See the full criteria
Where Is This Study? (1 UK site)
University Hospitals of Leicester
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351How to Get in Touch
Oreste D Gentilini, Dr
Sponsor contactCONTACT
Rosa Di Micco, Dr
Sponsor contactCONTACT