RecruitingOBSERVATIONAL

International Prospective REgistry on Pre-pectorAl Breast REconstruction

This international study is gathering information about a specific type of breast reconstruction called 'pre-pectoral' reconstruction. This means that after surgery for breast cancer, an implant is placed in front of, rather than under, the chest muscle. Doctors want to see how well this method works by looking at things like the success of the surgery, how the new breast looks, whether the cancer comes back, and how women feel about their quality of life afterwards. It's an observational study, meaning your treatment would not change. The information collected will help guide treatment choices for future patients.

At a glance

Status

Recruiting

Sponsor

IRCCS San Raffaele

Enrolment target

1,236

Start

12 Sep 2023

Estimated completion

10 Sep 2027

Breast Cancer

What is this study about?

This study, called the International Prospective REgistry on Pre-pectorAl Breast REconstruction, is looking at a specific way of rebuilding the breast after surgery for breast cancer. When a breast is removed due to cancer (this is called a mastectomy), some women choose to have a new breast created. This study focuses on a method where an implant (often made of silicone) is placed just under the skin, on top of the chest muscle, rather than underneath it. This is known as 'pre-pectoral reconstruction'.

The main goal is to carefully collect information from many women around the world who have this type of reconstruction. Doctors want to understand everything from how the surgery goes, to how the new breast looks and feels, how the cancer treatment progresses, and how this affects a woman's overall quality of life. By gathering all this data, they hope to get a clear picture of how effective and suitable this reconstruction technique is.

It's important to know that this is an 'observational' study. This means that if you take part, your doctors will continue to treat you as they normally would. The study won't change any part of your diagnosis or treatment plan. They will simply observe and record information about your journey. The information gathered will be incredibly valuable for future patients, helping doctors to make better decisions about the best type of breast reconstruction for each individual.

Key takeaways

Study collects information on breast reconstruction above the chest muscle.
It's for women having a mastectomy for breast cancer.
Your medical treatment and care won't change if you participate.
No extra risks are expected from joining the study.
Information gathered will help future patients make choices about reconstruction.

Who may be eligible?

To be able to take part in this study, you need to be a woman over the age of 18. You must be having a mastectomy (surgery to remove one or both breasts) because of breast cancer, and then having a specific type of breast reconstruction where an implant or tissue expander is placed in front of your chest muscle. You'll also need to sign a form saying you understand the study and agree to take part.

You wouldn't be able to join the study if you are a man. Similarly, if your doctors consider you unsuitable for surgery in general, or if you are having breast reconstruction where the implant is placed under the chest muscle, or if your new breast is being created using your own body tissue, then this particular study wouldn't be for you.

Quick self-check

Are you a woman aged 18 or over?
Are you having a mastectomy for breast cancer?
Are you having breast reconstruction where an implant is placed in front of your chest muscle?
Are you able to provide your written consent to take part?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, your doctors will simply observe and record information about your regular treatment path for breast cancer and your pre-pectoral breast reconstruction. You will continue to have your usual appointments, checks, and any medication as planned by your medical team. The study doesn't involve any extra visits or changes to your treatment. They will just be collecting information from your medical records and potentially asking about your quality of life at different stages. The study will follow about 1,236 patients through their reconstruction journey.

Potential risks and benefits

There are no expected risks for patients taking part in this study, as it's an observational study and won't change your medical care or treatment plan. The information gathered will be about your standard care. The main benefit is for future patients, as the detailed information collected will help doctors make better-informed decisions about the best type of breast reconstruction for individuals, particularly those considering the pre-pectoral approach. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (11)

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, Italy· Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 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

Common questions

What is 'pre-pectoral breast reconstruction'?

It's a way of rebuilding the breast after a mastectomy where an implant is placed in front of, rather than under, your chest muscle.

Will taking part in this study change my treatment?

No, this is an observational study. Your treatment plan for breast cancer and reconstruction will not be changed by taking part.

Are there any extra tests or appointments?

No, you won't have any extra tests or appointments just for this study. Doctors will use information from your regular medical care.

Will I get any direct benefit from joining?

You won't get a direct personal benefit. The main benefit is for future patients, as the study will help doctors understand this reconstruction method better.

Can I stop being part of the study if I change my mind?

Yes, you can choose to stop participating at any time, and it will not affect your medical care.

How to find out more

Oreste D Gentilini, Dr

gentilini@eubreast.com +390226431 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.