Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

This study is looking for both women (including those before or after menopause) and men aged 18 or older. For women who are still having periods, they would need to take another medicine that stops their ovaries from producing hormones, and then continue taking it throughout the study.

To join, you must have advanced breast cancer that is 'hormone receptor-positive' and 'HER2-negative'. This means your cancer cells are affected by hormones but don't have high levels of the HER2 protein. Your cancer must also have either spread to other parts of the body or be in a locally advanced stage where surgery isn't possible to cure it. Importantly, your cancer must have grown or come back after you've already had a type of hormone treatment called an aromatase inhibitor (AI). This could be during your AI treatment or within 12 months of finishing it.

Also, your cancer needs to be measurable, meaning doctors can see and track changes in its size using scans like CT or MRI. You should also be generally well enough to take part in the study, which doctors assess using a specific scoring system. The study will also require a sample of your tumour tissue for central testing.

If you decide to take part in this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive capivasertib plus fulvestrant, and the other will receive a placebo (dummy drug) plus fulvestrant. Neither you nor your doctors will know which group you are in, which helps ensure the study results are fair and accurate. You'll take the study medication regularly, and you'll have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI) to see how the treatment is working and to monitor any side effects.

You'll also continue to receive your LHRH agonist if you are a pre-menopausal woman. Your participation will involve ongoing treatment and monitoring for a period, and after the treatment phase, there will be follow-up appointments to track your health. The total duration of your involvement would depend on how the treatment works for you and the study protocol, but typically these kinds of studies involve treatment until the cancer progresses or side effects become too difficult to manage, followed by regular follow-ups.