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:

• Women aged 18 or older who are either postmenopausal (including those who have had both ovaries removed, are aged 60 or older, or are under 60 with confirmed natural menopause based on hormone blood tests) or premenopausal/perimenopausal women willing to receive a hormone-suppressing injection during the study.
• People with breast cancer that has been confirmed by biopsy as hormone receptor-positive (HR+) and HER2-negative, based on specific laboratory test results meeting defined thresholds.
• People whose cancer has come back or spread, is not suitable for curative surgery or radiation, and does not currently require chemotherapy.
• People whose cancer progressed during or shortly after a previous hormone therapy — either as a preventive treatment after initial diagnosis, or as treatment for cancer that had already returned or spread.
• People who have received no more than one round of chemotherapy since the cancer returned or spread.
• People who are considered generally well enough to carry out daily activities with little or no limitation (confirmed with trial site using a standard medical scale).
• People who have measurable cancer lesions on scans, or bone-only spread (including certain types of bone lesions), as assessed by standard imaging criteria.
• People whose blood counts and organ function (kidneys, liver, and heart) meet specific minimum levels as measured by blood tests and heart tracing.
• Women who could potentially become pregnant must have a negative pregnancy blood test within 7 days before starting the study drug and must be willing to use a highly effective contraceptive method throughout the study and for one year after the last dose.
• People whose side effects from any previous cancer treatment have mostly resolved before joining the trial.
• People who have given written consent and are willing and able to attend visits and follow the study schedule.

Who may not be able to join:

• People whose cancer has spread to internal organs in a way that causes serious symptoms, or whose condition may become life-threatening in the short term — for example, those with uncontrollable fluid build-up in the chest, abdomen, or around the heart, cancer spreading through the lung's lymph system, or cancer involving more than half the liver.
• People with active, symptomatic, or growing cancer spread to the brain or spinal cord — though those with a history of brain metastases that have been treated and have been stable for at least 4 weeks (and are off certain medications) may be considered (confirm with trial site).
• People who have previously been treated with fulvestrant, everolimus, or any CDK4/6 inhibitor medicines.
• People who have had surgery or radiation therapy within 14 days before starting the study and have not fully recovered, or who have received chemotherapy or other cancer treatments within 14 days (or within five half-lives of that treatment, whichever is longer) before starting.
• People diagnosed with another cancer within the past 3 years, with the exception of certain treated skin cancers or cervical pre-cancer.
• People with HIV infection or AIDS; active hepatitis B with detectable virus levels that cannot be reduced with antiviral treatment before starting; active hepatitis C with detectable virus levels; or a combined hepatitis B and C infection.
• People who have experienced certain serious heart or blood vessel events in the past 6 months, such as a heart attack, unstable chest pain, significant heart failure, certain abnormal heart rhythms, atrial fibrillation, bypass surgery, stroke, or blood clots in the lungs.
• People who had a serious infection requiring intravenous treatment within 4 weeks before starting, or who have an unexplained fever above 38.5°C during the screening period.
• People who are unable to swallow tablets or have a condition that would prevent them from properly absorbing the study medication.
• People with known blood clotting problems, or who are taking blood-thinning medications that may be incompatible with certain injections used in the trial.
• People with a known allergy to fulvestrant, the hormone-suppressing injection (goserelin), the study drug (BEBT-209 or its placebo), or any of their ingredients.
• People who have previously received an organ transplant or bone marrow/stem cell transplant from another person.
• People with a known history of substance abuse or drug addiction.
• People with poorly controlled diabetes, as assessed by the treating doctor.
• People with poorly controlled high blood pressure, as assessed by the treating doctor.
• People with other serious physical or mental health conditions, or significant abnormal test results, that the treating doctor considers would make participation unsafe or affect the study results.

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