This clinical trial is focused on studying treatments for Estrogen Receptor-Positive, HER2-negative Advanced Breast Cancer. The study will compare the effectiveness of a new treatment combination, Camizestrant (also known as AZD9833) plus a CDK4/6 inhibitor, against the current standard treatment of an Aromatase Inhibitor (such as Letrozole or Anastrozole) plus a CDK4/6 inhibitor. The purpose of the study is to determine if switching to the new treatment combination is more effective in patients who have a specific genetic change called the ESR1 mutation and have not experienced disease progression during their initial treatment.
Participants in the study will be randomly assigned to receive either the new treatment combination or continue with the current standard treatment. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know which treatment is being given to each participant. This helps ensure that the results are not biased. The study will last for a period of up to 77 weeks, during which participants will take the medications orally in the form of tablets or capsules. Some participants may receive a placebo, which looks like the real medication but does not contain the active substance.
The main goal of the study is to assess the progression-free survival, which is the time during which the cancer does not get worse. Secondary goals include evaluating overall survival, response rates to the treatment, and the time until further cancer treatment is needed. The study will also monitor the concentration of Camizestrant in the blood and assess changes in quality of life using specific questionnaires. This trial aims to provide valuable information on whether the new treatment combination can offer better outcomes for patients with this type of breast cancer.
Austria 
Belgium 
Bulgaria 
France 
Germany 
Hungary 
Italy 
Norway 
Poland 
Portugal 
Slovakia 
Spain 