CT7001_002 (SUMIT-BC) - An open-label Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant with or without Samuraciclib in Participants with Metastatic or Locally Advanced Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

To be considered for this study, you need to be at least 18 years old and have breast cancer that is either locally advanced (meaning it has grown into nearby tissues but hasn't spread far) or metastatic (meaning it has spread to other parts of your body).

Your breast cancer must also be 'hormone receptor positive,' which means its growth is linked to hormones, and 'HER2 negative,' meaning it doesn't have an excess of a specific protein called HER2. Both men and women can potentially take part in this study. There will be other specific medical criteria that your doctor will check to see if this study is right for you.

If you decide to take part in this study, you would receive either the standard breast cancer treatment called Fulvestrant (given as an injection) or Fulvestrant combined with the new investigational tablet, Samuraciclib. You won't be able to choose which treatment group you are in; this will be decided by chance, like flipping a coin.

Throughout the study, you would have regular hospital visits for assessments. These visits will involve blood tests, physical examinations, and scans (like CT scans) to check how the treatment is working and to monitor your health. Your doctor and the study team will explain exactly how often these visits will be and for how long. The total duration of your participation will depend on how you respond to the treatment and will be discussed with you in detail.