Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

This study is looking for women aged 18 or over who have been diagnosed with a specific type of ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Your cancer must be identified as 'high-grade serous' or 'high-grade endometrioid'. A key requirement is that you must have a confirmed fault in your BRCA1 or BRCA2 genes, which is known or expected to cause a problem with how the gene works.

To be eligible, you need to have received at least two previous rounds of platinum-based chemotherapy. Importantly, your cancer must have responded well to these treatments. This means that after your most recent chemotherapy, your cancer either completely or partially shrunk, or there’s no sign of the disease, and your CA-125 blood test levels are stable, indicating good control. You also need to have received at least four cycles of your last platinum-based chemotherapy and still be within eight weeks of your *last* dose when you join the study.

There are also some reasons why you might not be able to join. For example, if your BRCA gene change is considered harmless or of uncertain significance, you wouldn't be eligible. Also, if you’ve had fluid drained from your abdomen (ascites) during the last two cycles of your final chemotherapy, you wouldn't be able to participate. The study team will review all your medical information to confirm if you meet all the necessary criteria.

If you decide to take part in this study, you will be randomly assigned to receive either Olaparib tablets or a placebo (dummy) tablet. This is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving until the study is over. You will take the tablets regularly as instructed by the study team.

You will have regular appointments at the hospital for check-ups. These appointments will involve blood tests, physical examinations, and scans (such as CT scans) to monitor your cancer and your general health. The frequency of these visits will be determined by the study design but will likely be more frequent at the beginning and then less often over time.

Taking part in the study means you will be closely monitored for your health and any side effects from the treatment. You will continue to take the study tablets and attend follow-up appointments until your cancer gets worse, you experience severe side effects, or you decide to withdraw from the study. The total duration of your participation will depend on how you respond to the treatment, but the follow-up period could last for several years.