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CompletedObservational

Does removing both ovaries prior to menopause reduce breast cancer risk in BRCA1 and BRCA2 mutation carriers?

This study is investigating whether removing both ovaries and fallopian tubes before menopause can lower the risk of breast cancer in women who have inherited changes in the BRCA1 or BRCA2 genes. Currently, there isn't clear guidance on this, and doing a new study where women are randomly assigned to have surgery or not is difficult. Instead, researchers are looking at health information that has already been collected from different groups of women. They will combine and analyse this data to find out if early removal of ovaries and fallopian tubes makes a difference. They also want to see if having the surgery at a younger age has a bigger impact. This is an important step to help understand how best to advise women with these gene changes in the future.

At a glance

Status
Completed
Sponsor
Cancer Council Victoria
Enrolment target
5,500
Start
30 Nov 2025
Estimated completion
01 Feb 2026

What is this study about?

You might be wondering if removing your ovaries and fallopian tubes before menopause can lower your chance of getting breast cancer, especially if you have a change in your BRCA1 or BRCA2 gene. These gene changes are known to increase the risk of certain cancers. Currently, medical experts don't all agree on whether this operation truly helps reduce breast cancer risk for women with BRCA gene changes, and there are no clear international guidelines.

Because it would be very difficult to carry out a new study where women are asked to choose between surgery and no surgery, researchers are taking a different approach. They are looking at existing health records and information from many women who have already been part of other health studies. By combining and carefully analysing all this data, they hope to get a clearer picture. They want to understand if this operation makes a difference for breast cancer risk in women with BRCA1 and BRCA2 gene changes, and whether having the operation at a younger age is more effective.

This study won't involve any new treatments or procedures for patients. Instead, it's about making sense of information that has already been collected. The results could be very important in helping doctors and genetic counsellors give better advice to women who carry these gene changes about how to manage their cancer risk.

Key takeaways

  • The study investigates if removing ovaries/fallopian tubes before menopause lowers breast cancer risk for BRCA1/2 carriers.
  • It uses existing health records, so no new patients are involved.
  • Aims to clarify conflicting advice on risk-reducing surgery.
  • Will explore if surgery at younger ages has a greater impact.
  • Results could help improve future guidance for women with BRCA gene changes.
  • No direct risks or benefits to individuals whose data is used.

Who may be eligible?

This study won't involve new participants because it uses existing health information. The researchers will look at data from women who meet certain criteria. These include women with a definite harmful change in their BRCA1 or BRCA2 gene. They must have been born after 1920 and been at least 18 years old when their health information was first collected for previous studies.

Also, to be included in this analysis, women must not have had cancer (except for a very early stage cervical cancer or common skin cancers) or a preventative mastectomy (breast removal surgery) before their health records were first collected. Finally, there needs to be enough information available about their health journey, including whether they developed breast cancer or passed away, to help the researchers draw conclusions.

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.

  1. Do you have a harmful change in your BRCA1 or BRCA2 gene?
  2. Were you born after 1920?
  3. Did you not have cancer (except very early cervical or skin cancer) when your health records were first collected for other studies?
  4. Did you not have a preventative breast removal surgery when your health records were first collected?
  5. Is there existing health information about your medical history from previous studies?
Answer every question to see your result.

What does participation involve?

This study is different because it doesn't involve you directly taking part in any new appointments, tests, or treatments. Researchers are only looking at health information that has already been collected from women in previous studies. This means there are no study visits, medications to take, or follow-up appointments required from you. The researchers will simply be analysing existing data, and you won't need to do anything at all.

Potential risks and benefits

Since this study is only looking at existing health records, there are no direct benefits or risks to you as an individual. You won't have to change anything you're doing, and your personal health won't be affected by the study itself. However, the information gathered from this research could be very important. The results might help doctors and healthcare professionals in the future to better guide women with BRCA1 or BRCA2 gene changes on how to reduce their breast cancer risk. You have the right to withdraw your data from previous studies at any time, but this will need to be done through the original study that collected your information.

Locations (22)

  • NRG Oncology
    City only
    Philadelphia, United States of America
  • Columbia University
    Approximate
    New York, United States of America
  • Cancer Prevention Institute of California
    City only
    Fremont, United States of America
  • Cancer Care Ontario
    City only
    Toronto, Canada
  • Fox Chase Cancer Centre
    City only
    Philadelphia, United States of America
  • The University of Utah Health Sciences Centre
    Unverified
    Salt Lake City, United States of America
  • The University of Melbourne
    Unverified
    Parkville, Australia
  • University of Pennsylvania
    Unverified
    Philadelphia, United States of America
  • Vall d'Hebron University Hospital
    Unverified
    Barcelona, Spain
  • University of Cambridge
    Unverified
    Cambridge, United Kingdom
  • Institute Paoli-Calmettes
    Unverified
    Marseille, France
  • The Netherlands Cancer Institute
    Unverified
    Amsterdam, Netherlands

Common questions

What are BRCA1 and BRCA2 genes?

These are genes that usually help protect you from cancer. But if they have certain changes (mutations), they can increase your risk of developing breast and ovarian cancer.

What is 'menopause'?

Menopause is when a woman's periods stop permanently, usually around the age of 45 to 55. It marks the end of her reproductive years.

What does 'removing both ovaries and fallopian tubes' mean?

This is a surgical operation, often called a bilateral salpingo-oophorectomy. It involves taking out both ovaries (which produce eggs and hormones) and both fallopian tubes (which carry eggs to the womb).

Will my personal details be safe?

Yes, when researchers use existing health data, they follow strict rules to protect your privacy. Your personal information would be kept confidential and anonymised wherever possible.

Who is paying for this research?

This study is being funded by Cancer Council Victoria, an organisation based in Australia, using their own funds.

How to find out more

Stephanie Nesci

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

Discussion

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