Phase 3 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 75 years old
• People who have a confirmed diagnosis of breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-)
• People who have not previously had any systemic (whole-body) anti-cancer treatment for locally advanced or metastatic breast cancer
• People with a general health score of 0 or 1 on a standard scale used by doctors to measure how well a person can carry out daily activities (ECOG scale)
• People whose liver, kidneys, bone marrow, and other organs are functioning well enough to meet the trial's requirements
• People who are willing to read and sign a consent form agreeing to take part

Who may not be able to join:

• People who have previously been treated with a type of drug called a CDK4/6 inhibitor
• People who have a known allergy to the study drug GB491 or to any ingredient in Letrozole
• People who have been confirmed to have HER2-positive breast cancer
• People who have brain or spinal cord cancer spread (metastases) that are uncontrolled or causing symptoms
• People who have had major surgery, chemotherapy, radiation therapy, another experimental drug, or other cancer treatment within 4 weeks before joining the trial (or who are expected to need major surgery during the trial)
• People who have previously received chemotherapy for breast cancer that has come back locally or spread to other parts of the body
• People who have had serious heart or blood vessel problems — such as a severe heart attack in the last 6 months, unstable or severe chest pain (angina), heart failure, or an irregular heartbeat requiring medical treatment
• People who have a known history of HIV infection or a positive HIV test result

Important: Always verify eligibility with the trial site directly before applying.