Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 diagnosed with breast cancer that tests positive for hormone receptors (estrogen or progesterone), meaning at least 1% of cancer cells show hormone receptor activity on a lab test.
• People whose breast cancer tests negative for a protein called HER2, meaning the cancer does not overproduce this protein.
• People who have 15 or fewer brain metastases (areas where cancer has spread to the brain) that are suitable for a targeted type of radiation called stereotactic radiation.
• People who are able to swallow tablets or capsules by mouth.
• People who are willing and available to follow all study requirements for the full duration of the trial.
• People who have measurable cancer in the brain that can be seen on scans and is at least 0.5 cm in size (in at least one direction), whether the tumour is intact or in an area where surgery has been performed.
• People whose brain metastases are suitable for a precise, targeted radiation treatment called stereotactic radiosurgery (SRS), either to an existing tumour or to the area where a tumour was surgically removed.
• People whose largest individual brain tumour is no more than 4 cm across at its widest point.
• People who have a general health and activity level rated as reasonably functional on a standard medical scale (ECOG performance status 0 to 2 — confirm with trial site for exact meaning).
• People for whom a stored or recently collected tumour tissue sample can be provided for research testing, though this is not a firm requirement if samples cannot be obtained.
• People who have previously had targeted brain radiation (SRS or FSRT), provided the areas with currently active, measurable disease have not already been treated with radiation.
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study medication (abemaciclib).
• Women who could become pregnant must agree to use contraception throughout the treatment period and for three weeks after the last dose of the study medication.
• People with adequate organ function as defined by the trial's testing requirements (confirm with trial site for specific details).

Who may not be able to join:

• People whose cancer has spread to the lining surrounding the brain and spinal cord (called leptomeningeal disease).
• People who have previously received whole-brain radiation therapy.
• People who have previously been treated with the study drug abemaciclib specifically for brain metastases, or who have received it for metastatic disease within the past 6 months.
• People who still have significant side effects from previous cancer treatments that have not improved to a mild or baseline level, with some exceptions for lasting effects (such as nerve damage from certain chemotherapies) or minor issues like fatigue or hair loss that are not expected to interfere with the study.
• Women who are currently pregnant or breastfeeding.
• People with serious or poorly controlled ongoing health conditions that the trial doctor believes would make participation unsafe — examples include certain lung conditions, severe breathing problems, severely reduced kidney function, major previous stomach or small bowel surgery, or ongoing inflammatory bowel conditions causing frequent diarrhoea.
• People with an active serious infection at the time of starting treatment, such as a bacterial infection requiring intravenous antibiotics, an active fungal infection, or known active HIV, hepatitis B, or hepatitis C.
• People with a personal history of fainting due to a heart-related cause, dangerous heart rhythm problems (such as ventricular tachycardia or fibrillation), or sudden cardiac arrest.
• People who have had another cancer diagnosed within the past 2 years, unless that cancer was considered very unlikely to spread or cause death (for example, certain skin cancers or early-stage uterine cancer — the trial doctor makes this determination).
• People who have not yet fully recovered from major surgery or a serious injury within 14 days before starting the study treatment.
• People who have taken part in another clinical trial involving an experimental drug or device within the 2 weeks before starting this study.
• People who have a known allergy or serious reaction to any of the study drugs or their ingredients.
• People who are prisoners or are involuntarily held in a facility.

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