Phase 1 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:

• You have been diagnosed with breast cancer that is hormone receptor-positive and HER2-negative (confirmed by a tissue or fluid sample), and the cancer has spread to other parts of the body.
• Your cancer has a specific gene change called an ESR1 mutation, found through a tumor or blood test.
• You have already received at least one hormone therapy treatment and a CDK 4/6 inhibitor drug for your metastatic (spread) cancer.
• Your cancer can be seen and measured (or at least detected) on a scan.
• You are able to carry out basic daily activities with little to no limitation (your doctor can confirm this using a standard performance scale).
• You are 18 years of age or older.
• You are able to read and speak English or Spanish.
• Your blood test results show that your bone marrow, liver, and kidneys are functioning well enough (your doctor will check specific lab values).
• If you could become pregnant, you have had a negative pregnancy test before joining the trial.
• If you are sexually active with a male partner and could become pregnant, you agree to use effective birth control during the study.
• You are willing and able to follow all study requirements for the full duration of the trial.
• You are willing to sign a consent form (or have a legal representative sign on your behalf).
• You have brain metastases (cancer that has spread to the brain) that have already been treated and are stable, with no signs of growth in the 2 months before joining the trial.
• People of all racial and ethnic backgrounds who meet the criteria are welcome to apply.

Who may not be able to join:

• You are currently pregnant or breastfeeding.
• You have previously been treated with a drug called Elacestrant.
• You have had a serious allergic reaction to any of the drugs used in this study.
• You have brain or spinal fluid metastases that are new, active, or getting worse.
• You have taken another experimental (investigational) treatment within the last 21 days.
• You have received certain cancer treatments within the last 14 days, including chemotherapy, hormone therapies (such as tamoxifen, aromatase inhibitors, or fulvestrant), or targeted therapies (such as CDK 4/6 inhibitors or similar drugs).
• You have been diagnosed with or treated for another cancer (other than certain skin cancers or fully removed non-invasive cancers) within the past 2 years, or still have signs of another cancer.
• You have serious uncontrolled health conditions, such as an active infection, severe heart problems, or mental health or personal circumstances that would make it hard to follow the study plan.
• Your cancer has spread severely to internal organs in a way that could cause life-threatening complications very soon (for example, large uncontrolled fluid build-up or cancer in the lung's lymph vessels).
• You have a known history of HIV or AIDS.
• You have an active infection including tuberculosis, active hepatitis B, or active hepatitis C (confirm with trial site for specific details about past infections).
• You have taken immune-suppressing medications within the last 14 days (with some exceptions, such as low-dose steroids or allergy pre-medications — confirm with trial site).
• You are unable or unwilling to follow the study's requirements.

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