Phase 2 Brain 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 signed a consent form before any study-related activities begin, in line with local guidelines.
• Adults aged 18 or older at the time of signing the consent form.
• Women who are post-menopausal (defined as being aged 60 or over; or under 60 with no menstrual period for 12 or more months without another explanation and hormone levels in the post-menopausal range; or having had both ovaries surgically removed at least one month before the first dose of trial treatment).
• Women who are pre-menopausal or peri-menopausal, and men, who are already receiving — or will begin receiving at least 3–4 weeks before the trial starts — a hormone-suppressing injection called an LHRH agonist, and who plan to continue this throughout the study.
• People whose breast cancer tumour has tested positive for oestrogen receptors (ER-positive) and negative for HER-2, confirmed by a local laboratory using recognised testing standards.
• In Phase 2 of the trial: people who have at least one active and measurable brain metastasis (a tumour that has spread to the brain) that is at least 10mm in size on a CT or MRI scan, and which is either newly found, located outside a previously treated area, or has clearly grown in a previously treated area.
• In Phase 1b of the trial: people with or without brain metastases are eligible, but at least one measurable tumour outside the brain (at least 10mm) is required.
• People taking steroid medications (corticosteroids) who have been on a stable or reducing dose for at least 7 days before the baseline assessment, and who are not taking more than 4mg of dexamethasone per day (or the equivalent dose of another steroid).
• People who have had no more than one seizure in the 4 weeks before starting trial treatment.
• People whose prior treatment for metastatic breast cancer included at least one hormone (endocrine) therapy, no more than two chemotherapy regimens, and no more than two lines of a type of drug called a CDK 4/6 inhibitor (not including the drug abemaciclib).
• People whose cancer has been confirmed by scans to have grown or returned during or after their most recent treatment.
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (ECOG performance status), meaning they are able to carry out at least some daily activities (confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People whose blood tests show that their bone marrow and organs are functioning at an adequate level, including acceptable levels of blood cells, kidney function, liver function, and certain minerals (confirm specific values with trial site).
• People who are willing and able to attend study visits and follow the study requirements.

Who may not be able to join:

• People whose doctor believes they urgently need treatment directed specifically at tumours in the brain before the trial can begin.
• People experiencing imminent failure of a major organ or a medical crisis affecting internal organs.
• People whose cancer has spread to the lining of the brain or spinal cord (leptomeningeal metastases), confirmed by a spinal fluid test or clear imaging and clinical evidence.
• People who have not yet received any systemic (whole-body) treatment for advanced or metastatic breast cancer.
• People who have had a pulmonary embolism (blood clot in the lungs), stroke, or heart attack in the 6 months before the screening visit.
• People who have previously been treated with the drug abemaciclib for metastatic breast cancer. (Note: abemaciclib used in an earlier, non-metastatic setting may be acceptable if the last dose was more than 12 months before the first recurrence — confirm with trial site.)
• People who have previously been treated with elacestrant or certain other investigational hormone-targeting drugs (including SERDs, SERMs, SERCANs, CERANs, or PROTACs) for metastatic breast cancer.
• People who have or have had another cancer diagnosis within the past 3 years, with some exceptions such as certain treated skin cancers, early-stage bladder cancer, cervical cancer in situ, a second primary breast cancer, or another cancer considered fully in remission by the investigator (confirm with trial site).
• People who are currently taking part in another breast cancer treatment clinical trial.
• People who have received certain recent anti-cancer treatments within specified timeframes before the first dose — including fulvestrant within 42 days, other hormone therapies within 14 days, chemotherapy within 14 days, other investigational anti-cancer drugs within 28 days or 5 half-lives (whichever is shorter), or recently started or changed bone-strengthening medications (bisphosphonates or RANKL inhibitors) within 1 month.
• People who have had radiation therapy (including to the brain) within 7 days before the first dose, or who have not fully recovered from the side effects of recent radiotherapy.
• People with serious active infections that are not controlled; people with hepatitis B or C must have undetectable levels of the virus at screening; people who are HIV-positive may be eligible if their viral load is undetectable at baseline.
• People who have had major surgery within 4 weeks before starting trial treatment.
• People who are unable to swallow oral medication, or who have a condition that significantly affects how the body absorbs medication through the digestive system.
• Women who are able to become pregnant and who do not agree to use a highly effective non-hormonal contraceptive method (such as a non-hormonal IUD, sexual abstinence, tubal ligation, or a partner with confirmed vasectomy and azoospermia) from 28 days before the first dose until 120 days after the last dose, and to refrain from donating eggs during this period.
• Male participants (including those who have had a vasectomy) with a pregnant partner or a partner who could become pregnant, who do not agree to use condoms from 28 days before the first dose until 120 days after the last dose, and who do not agree to refrain from freezing or donating sperm during this period; female partners of childbearing potential of male participants who have not had a vasectomy must also use highly effective contraception.
• Women who are pregnant or breastfeeding, or who do not agree to avoid pregnancy during treatment and for 120 days after the last dose, or to avoid breastfeeding during treatment and for 1 week after the last dose.
• People who are known to be intolerant to either of the study drugs or any of their ingredients.
• People currently taking, or who have recently taken, medications or supplements that strongly or moderately affect the way the body processes certain drugs (CYP3A4 inducers or inhibitors) within 14 days or 5 half-lives before the first dose; certain herbal supplements (such as kava, ginkgo biloba, ginseng, and others) within 7 days before starting; or who have received a vaccination (including COVID-19) within 7 days before joining the trial.
• People with a serious medical or psychiatric condition that, in the investigator's opinion, would prevent safe participation in the trial.

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