RecruitingOBSERVATIONAL

Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer

This study is investigating the long-term safety of a type of breast surgery called nipple-sparing mastectomy. This operation allows women at high genetic risk of breast cancer to have a mastectomy (breast removal) to reduce their risk, while also keeping their nipple and the darker skin around it (areola). Many women prefer this option for their body image and well-being, but there isn't much long-term information yet on how safe it is, especially for preventing future cancers when compared to other types of mastectomy. This research aims to provide more clear answers by following women with specific genetic changes for a longer time, helping doctors give the best advice.

At a glance

Status

Recruiting

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrolment target

4,700

Start

01 Feb 2025

Estimated completion

01 Feb 2028

Breast Cancer Surgery

What is this study about?

Imagine you have a strong family history of breast cancer, or genetic test results show you have a higher chance of developing it. One option some women consider is surgery to remove their breasts to significantly lower this risk. This is called a risk-reducing mastectomy.

There are different ways to do this surgery. Historically, the nipple and the skin around it were removed. However, a newer technique called 'nipple-sparing mastectomy' allows surgeons to remove the breast tissue, but keep the nipple and areola intact. Many women find that keeping these parts of their breast helps them feel much better about their body and reduces feelings of disfigurement after surgery.

Even though nipple-sparing mastectomy can have these important benefits for a woman's well-being, doctors still need more long-term information to be absolutely sure it's as safe as other types of mastectomy for cancer prevention, especially for women with certain genetic risks. This study aims to gather that important long-term safety data. By following women for a longer time, researchers hope to confirm whether this type of surgery is just as effective at preventing breast cancer in those at high genetic risk.

Key takeaways

The study explores the long-term safety of nipple-sparing mastectomy.
It's for women with specific genetic risks for breast cancer.
The goal is to provide clearer evidence on this surgery for cancer prevention.
Many women prefer this surgery for body image.
More long-term data is needed for medical guidelines.

Who may be eligible?

This study is looking for women who were assigned female at birth and are 18 years old or older. You would need to have had a genetic test that confirmed you carry specific changes in certain genes known to increase the risk of breast cancer. These genes include BRCA1, BRCA2, PALB2, TP53, CDH1, or PTEN.

You wouldn't be able to join if you have already had breast cancer, or if you had ovarian cancer before your genetic testing. Also, if you've already had both breasts removed before your genetic test, you wouldn't be suitable for this study. Finally, if your genetic test showed a 'variant of uncertain significance' – meaning genetic changes whose role isn't yet fully understood – as your only genetic finding, this study wouldn't be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman and was assigned female at birth.
I am 18 years old or older.
I have had a genetic test that confirmed a specific genetic change (like BRCA1 or BRCA2) that increases my breast cancer risk.
I have never had breast cancer before my genetic test.
I have never had ovarian cancer before my genetic test.
I have not had both breasts removed before my genetic test.

Answer every question to see your result.

What does participation involve?

The description does not provide details on what participation would involve in terms of visits, assessments, medication, or specific follow-up schedules. It mentions a focus on longer follow-up to confirm previous findings. To get a clear understanding of what joining this study would mean for you, you would need to speak directly with the research team.

Potential risks and benefits

Participating in research studies like this can often provide important information that helps future patients. A potential benefit of this study is contributing to a better understanding of the long-term safety of nipple-sparing mastectomy for women with specific genetic risks, which could help many others make informed choices. The study itself is observational, meaning it's likely to involve collecting information rather than new treatments. While the specific risks of participation are not detailed here, generally, these might include time commitment for appointments or potential emotional impact when discussing medical history. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Yale University
Verified postcode
New Haven, United States· Recruiting
Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
Verified postcode
Boston, United States· Not yet recruiting
Memorial Sloan Kettering Cancer Center (MSKCC)
Verified postcode
New York, United States· Not yet recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
University of Melbourne, Peter MacCallum Cancer Center
Verified postcode
Melbourne, Australia· Not yet recruiting
Ziekenhuis Aan de Stroom
Verified postcode
Antwerp, Belgium· Active not recruiting
University of Calgary
Verified postcode
Calgary, Canada· Recruiting
Hamilton Health Sciences
Verified postcode
Hamilton, Canada· Recruiting
Women's College Hospital, University of Toronto
Verified postcode
Toronto, Canada· Not yet recruiting
Jewish General Hospital
Verified postcode
Montreal, Canada· Recruiting
CHU de Quebec Université laval
Verified postcode
Québec, Canada· Recruiting
Champalimaud Foundation, University of Lisbon
Verified postcode
Lisbon, Portugal· Not yet recruiting

Common questions

What is a 'nipple-sparing mastectomy'?

It's a type of surgery where breast tissue is removed to reduce cancer risk, but the nipple and the darker skin around it (areola) are kept.

Why is this study important?

It aims to confirm if nipple-sparing mastectomy is a safe long-term option for preventing breast cancer in women with certain genetic risks, especially since many prefer this surgery for their well-being.

Who can take part in this research?

Women aged 18 or over, who have specific genetic changes (like in BRCA1/2 genes) that increase their breast cancer risk, and who haven't had breast or ovarian cancer before their genetic testing.

What genes are they looking at?

The study is looking at women with changes in genes like BRCA1, BRCA2, PALB2, TP53, CDH1, or PTEN.

Will I get a new treatment in this study?

The study focuses on observing outcomes over time for women who have already had or are considering a nipple-sparing mastectomy, rather than providing a new treatment.

How to find out more

Stephanie Wong, MD

sm.wong@mcgill.ca 5143408222 Official trial record

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