Phase 2 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 who have been diagnosed with a specific type of breast cancer confirmed by lab testing — hormone receptor-positive (HR+), HER2-low or HER2-ultralow — that has either spread to other parts of the body or cannot be surgically removed.
• People who have previously been treated with a type of drug called a CDK4/6 inhibitor, and may also have had any number of hormone-based therapies for advanced or metastatic disease.
• People who have had no more than one prior round of chemotherapy or a specific type of drug called an antibody-drug conjugate (ADC) for metastatic disease.
• People whose cancer can be measured on scans or imaging (at least one tumour large enough to track according to standard medical measurement guidelines).
• People who have had a specific genetic test (ESR1 mutation status) on their tumour or blood within the past 6 months, or who are able to have that testing done before joining (confirm with trial site).
• Adults aged 18 years or older.
• People who are well enough to carry out basic daily activities, based on a standard medical fitness scale (ECOG score of 0, 1, or 2).
• People whose blood counts, liver function, kidney function, and heart function meet specific minimum levels as measured by recent blood tests and a heart scan (confirm with trial site for exact values).
• People with brain metastases (cancer that has spread to the brain) may still be eligible if those areas are stable or not causing symptoms and do not need immediate treatment — with some specific timing conditions if brain treatment has recently been given (confirm with trial site).
• Women who are post-menopausal, either naturally or through surgery or medication, meeting specific medical definitions (confirm with trial site).
• Women who are pre-menopausal and have a negative pregnancy test before joining.
• People who are willing and able to use reliable contraception throughout the trial and for a defined period after the last dose of study treatment.
• People who are able to swallow and keep down oral (tablet/capsule) medication.
• People who are able to understand the study and are willing to sign a consent form.

Who may not be able to join:

• People who have previously been treated with a type of drug called a topoisomerase inhibitor antibody-drug conjugate at any point.
• People who have previously received certain newer types of oestrogen-blocking drugs (such as SERDs, SERMs, PROTACs, or CERANs) for metastatic disease — though prior treatment with fulvestrant is allowed.
• People with brain metastases that are causing symptoms or that currently need treatment to control symptoms; also, people who had brain surgery or a brain biopsy within 4 weeks before starting the study.
• People who have taken another experimental drug or used an experimental device within 2 weeks before starting this trial.
• People with a history of allergic reactions to drugs chemically similar to the study medications (elacestrant or T-DXd).
• People who have had a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently show signs of a lung condition called interstitial lung disease on scans.
• People who are currently pregnant, breastfeeding, or who plan to become pregnant during the study period.
• People with active tuberculosis.
• People with certain serious uncontrolled health conditions, including active infections requiring treatment, recent stroke or heart attack (within the past 6 months), unstable chest pain, moderate-to-severe heart failure, serious irregular heart rhythms, uncontrolled diabetes, certain bowel or stomach conditions that could affect how the medication is absorbed, moderate or severe liver disease, active hepatitis B or C infection, or significant mental health or personal circumstances that could make it difficult to follow the study requirements.
• People with a history of another cancer, unless they have been cancer-free for at least three years and are considered low-risk for that cancer returning — with some exceptions for certain early-stage skin or cervical cancers diagnosed and treated within the past 5 years (confirm with trial site).

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