An ovarian cancer study

Can taking aspirin prevent ovarian cancer in women with the BRCA1 or BRCA2 gene mutations?

CCTG OV25 (NCT03480776): A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs)

What is the purpose of this study?

The CCTG OV25 (STICs and STONEs) study is looking to see if taking Acetylsalicylic Acid (ASA), commonly known as aspirin, every day can reduce the risk of ovarian cancer in women who are at high risk and have been identified as having the BRCA1 or BRCA2 genetic mutation.

Due to the presence of the BRCA1 or BRCA2 genetic mutation, women have an increased risk of getting ovarian cancer and are often offered surgery to reduce the possibility of the occurrence of cancer. This surgery involves taking out the fallopian tubes and ovaries. This study will look at tissue samples from fallopian tubes and ovaries that have been removed during preventative surgery.

The study will compare the tissue samples of women who:

• Took ASA every day before their surgery
• Did not take ASA before their surgery

Why is this study important?

ASA is not a cancer medicine, but studies show that taking ASA reduces the chance of getting many types of cancer because it reduces inflammation. Inflammation in the ovaries during a woman's period is thought to be a factor in ovarian cancer.

The study team will search for early signs of ovarian cancer in the tissue samples after preventative surgery has been completed. If taking ASA everyday results in less signs of early cancer in the tissue, then it may help prevent ovarian cancer.

Who can participate in this study?

• Women who have a gene mutation BRCA1 or BRCA2.
• Women who are considering surgery within 6 months to 2 years to reduce the risk of ovarian cancer.

What are the risks?

Describe most reasonably foreseeable risks of participation and study treatment. This should be consistent with the ICF.

The risks are the usual side effects of taking ASA and it is recommended that you do not fall pregnant during while you are participating in the trial. You will find details of all side effects in the consent document.

If you decide to join the study your will have too:

• Take the study pill (ASA or sugar pill)
• Have some tests (physical and pregnancy)
• Give some samples (tissue and blood)
• Fill out a questionnaire (survey)
• Keep track of your medications

How can I find out more or join the study?

Always talk to your doctors and other health care providers if you are considering joining a clinical trial. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

The CCTG OV25 study is currently accruing at centres in Canada. For a full list of participating centres please visit www.clinicaltrials.gov for the full details: OV25 (NCT03480776).

Joining a clinical trial

Before you decide to join any clinical trial, you will be asked to review an Informed Consent document. Discussion with your physician and the informed consent document will tell you more about why the research is being done and your role as a participant. Please ask the study doctor if anything is not clear or if you if you have questions.

Joining clinical trials is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.