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:

• People of any gender aged 18 or older at the time of diagnosis
• People who are able to understand and agree to the study requirements, and who are willing and able to attend treatment and follow-up appointments
• People who have signed a consent form before any study-related procedures begin
• People with a confirmed diagnosis of invasive breast cancer affecting one breast (people with cancer in both breasts, or cancer in multiple areas of one breast, may only be considered after the trial organisers are consulted)
• People whose breast cancer has been confirmed by tissue testing to be hormone receptor-positive — meaning the tumour has oestrogen receptors at 10% or higher and progesterone receptors at 10% or higher
• People whose breast cancer has been confirmed by tissue testing to be HER2-negative
• People with no signs that the cancer has spread to distant parts of the body, confirmed by relevant scans performed as part of routine care
• People whose tumour has been assessed and found to be at high genomic (genetic) risk, preferably using a specific test called Oncotype DX® (this test may be done after joining the trial if it could not be done beforehand, provided enough tumour tissue is available)
• People who have completed a short course of hormone-blocking treatment (called endocrine induction therapy) lasting 2 to 6 weeks, and who have had a follow-up tissue measurement taken (confirm with trial site if this step was not possible)
• People who have completed chemotherapy before or after surgery, if that was part of their treatment plan
• People who have completed radiotherapy, if that was part of their treatment plan
• People whose cancer stage and test results meet specific combinations of tumour size, lymph node involvement, genomic risk score, age, and other clinical factors at the end of primary treatment — this is a detailed set of criteria and the trial site will assess whether a person's results fit (confirm with trial site)
• People who have no medical reasons preventing them from receiving standard hormone-blocking treatment, the study drug elacestrant, or the study drug ribociclib (if medically recommended)
• People who are able to provide tumour tissue samples for central review, if available
• People who are in good general health, defined by a performance score showing they are fully active or have only minor limitations in physical activity
• People whose recent blood test results (taken within 14 days before signing consent) meet specific levels for blood counts, kidney function, liver function, and cholesterol and triglycerides — people whose cholesterol or triglyceride levels are slightly outside the required range may be considered after starting medication to manage those levels
• People whose heart tracing (ECG) recorded within 6 weeks before joining the trial shows a normal result within specified ranges
• People who are able to swallow tablets
• People who meet the required contraception conditions — female participants of childbearing potential must have a negative pregnancy blood test and use a highly effective non-hormonal contraceptive method throughout the study and for at least 4 months after the last dose of elacestrant and at least 21 days after the last dose of ribociclib; male participants must also use effective contraception during this period, including a condom and spermicide if their partner could become pregnant; hormonal contraception is not acceptable for female participants

Who may not be able to join:

• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who have had another cancer in the past 5 years, except for certain fully treated skin cancers or a specific type of pre-cancerous cervical condition
• People with a history of any invasive cancer in the last 10 years, with some exceptions for certain treated skin cancers, treated cervical cancer, or a specific breast condition in the opposite breast treated by full removal — a previous non-invasive breast condition in the same breast is excluded regardless of treatment
• People whose breast cancer has spread to distant parts of the body beyond nearby lymph nodes
• People currently receiving chemotherapy-type treatment for a non-cancer reason, unless the trial organisers have been consulted
• People currently taking part in another experimental treatment study
• People who have taken part in another interventional clinical trial within 30 days, or within 5 half-lives of that trial's drug (whichever is longer), before joining this trial — the trial organisers should be contacted if this applies
• People who have previously received more than 4 weeks of treatment with a type of hormone-blocking drug called a SERD
• People who are currently pregnant; people of childbearing potential or those with potentially childbearing partners must use effective non-hormonal contraception during the study
• People who are breastfeeding
• People currently using hormonal contraception (including oral, patch, injection, or implant) or hormonal replacement therapy
• People where there are concerns they may not be able to follow the study requirements reliably
• People who are not able to give their own consent
• People who have not recovered from significant side effects of previous cancer treatments (confirm with trial site regarding specific grading thresholds)
• People with serious ongoing health conditions that would interfere with hormone-blocking treatment or participation in the study
• People planned to receive ribociclib who have significant or uncontrolled heart conditions, including but not limited to: a heart attack, angina, or heart bypass surgery within the past 6 months; a diagnosed heart muscle disease; reduced heart pumping function below a specified level; certain heart rhythm problems or risk factors for dangerous heart rhythms; or blood pressure outside a specified range
• People with significant problems affecting the stomach or intestines that could interfere with how the study drugs are absorbed
• People with an active, uncontrolled infection requiring intravenous antibiotics, antiviral, or antifungal treatment
• People with a known immune deficiency condition or a confirmed HIV infection
• People with a known active hepatitis B or hepatitis C infection
• People who have received a live vaccine within 30 days before joining the trial
• People who have been placed in an institution by a court or government authority

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