Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

This study is looking for both women (before or after menopause) and men who are at least 18 years old and have advanced or metastatic breast cancer. This means your cancer has spread or cannot be removed with surgery. Your cancer must also be hormone receptor-positive and HER2-negative (HR+/HER2-), which are characteristics determined by tests on your tumour.

To be considered, your cancer must have continued to grow after you've already received standard treatments like a CDK4/6 inhibitor (for example, palbociclib) in combination with an aromatase inhibitor. Doctors will also need to be able to measure your cancer on scans to track how it responds to treatment. Your general health should be good, meaning you can carry out most daily activities, and your important organ functions (like liver, kidney, blood) need to be working well.

There are also some reasons why you might not be able to join, such as having certain other serious medical conditions or a history of other specific cancers. For women who can become pregnant, it's important to use effective contraception during the study and for a period afterwards.

If you decide to take part in this study, you will first undergo a series of tests to confirm your eligibility, including blood tests, scans, and possibly a review of your previous tumour biopsy to check for specific genetic changes. If you are eligible, you will be randomly assigned to one of the treatment groups, meaning a computer will decide which combination of medicines you receive. Your doctor and you will know which treatment arm you are in.

Your treatment will involve taking medication, some of which may be given through an IV (into a vein) and others as tablets. Throughout the study, you will have regular clinic visits for physical examinations, blood tests, and scans (like CT or MRI scans) to monitor your health, check for side effects, and see how the cancer is responding to treatment. The exact schedule of visits and tests will be explained in detail, but they are typically more frequent at the beginning and then become less frequent over time. While the total duration of your participation can vary, you will continue treatment as long as it is benefiting you and you are tolerating it well. After stopping the study treatment, there will also be follow-up appointments to track your long-term health.