This clinical trial is focused on studying treatments for a type of breast cancer known as hormone receptor-positive and HER2-negative breast cancer. This type of cancer is characterized by the presence of hormone receptors and the absence of a protein called HER2. The study involves patients with advanced stages of this cancer, which means it has spread beyond the breast and is not suitable for surgery. The trial is testing a new treatment combination that includes a medication called Capivasertib, along with other drugs known as CDK4/6 inhibitors—specifically Palbociclib, Ribociclib, and Abemaciclib—and a drug called Fulvestrant. These medications are taken orally, except for Fulvestrant, which is given as an injection.
The purpose of the study is to evaluate the safety and effectiveness of this new combination of treatments. The trial is divided into two phases. In the first phase, the focus is on assessing how safe and tolerable the combination is for patients. This means checking for any side effects and determining the best dose to use in the next phase. The second phase aims to see if the new treatment combination is better than the current standard treatment in delaying the progression of the cancer. This is measured by how long patients live without the cancer getting worse, known as progression-free survival. The study also looks at specific genetic changes in the cancer, such as PIK3CA, AKT1, and PTEN mutations, to see if these affect how well the treatment works.
Participants in the study will receive either the new treatment combination or the standard treatment, which includes CDK4/6 inhibitors and Fulvestrant. The study will monitor patients over a period of time to collect data on their health, any side effects, and the effectiveness of the treatment. This information will help determine if the new combination offers a better option for treating this type of breast cancer.
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