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 who are willing to take part and are able to give written consent
• Women aged 18 or older
• People who have been diagnosed with invasive breast cancer in one or both breasts, confirmed by tissue testing
• People who still have signs of invasive cancer remaining in the breast or nearby lymph nodes after receiving chemotherapy before surgery (called neoadjuvant chemotherapy)
• People whose cancer has been confirmed by tissue testing to be hormone receptor-positive (at least 1% of cells test positive for ER and/or PR) and HER2-negative; in cases of cancer in both breasts, tissue from both sides must be testable
• People whose cancer tissue has been tested for a marker called Ki67; in cases of cancer in both breasts, tissue from both sides must be testable
• People whose heart electrical activity (measured by an ECG) shows a specific reading called QTc below 450 milliseconds, with a resting heart rate between 50 and 99 beats per minute
• People who have completed at least 18 weeks of chemotherapy before surgery, including at least 6 weeks of a type of chemotherapy containing a taxane (an exception may apply for people whose cancer progressed after at least 6 weeks of taxane-containing treatment — confirm with trial site)
• People who have had adequate surgery to remove all visible disease, including appropriate treatment of the underarm lymph nodes, meeting specific surgical clearance standards depending on the type of surgery performed
• People whose randomisation into the trial happens within 16 weeks of their final surgery, or within 10 weeks of finishing radiotherapy, whichever happened most recently
• People who have completed radiotherapy according to standard guidelines, or where the reason for not having radiotherapy has been recorded (confirm with trial site)
• People with no signs that the cancer has come back locally or spread to other parts of the body during or after pre-surgery chemotherapy
• People whose cancer meets specific staging criteria, including certain tumour size and lymph node status combinations, or specific risk features such as high-risk test results, high grade, elevated Ki67, or lymphovascular invasion (confirm with trial site)
• People with a general health performance rating of 0 or 1 on a standard scale (meaning fully active or restricted in strenuous activity only)
• People whose side effects from previous cancer treatment or surgery have largely resolved to a mild level or better (with some exceptions at the treating doctor's discretion)
• People with an estimated life expectancy of at least 5 years, independent of their breast cancer diagnosis
• People who are able to attend all scheduled visits and receive treatment at a participating trial centre

Who may not be able to join:

• People whose cancer has spread to nearby lymph nodes (node-positive status), confirmed before or during surgery
• People with a known history of severe allergic reactions to drugs similar to ribociclib or to aromatase inhibitors
• People whose blood or organ function tests immediately before randomisation fall outside acceptable ranges, including low blood counts, elevated liver enzymes, high bilirubin, elevated creatinine, or reduced kidney function, or who have serious other health conditions that could interfere with participation
• People with signs of active infection, including wound infections, HIV, or any form of hepatitis
• People who received a cumulative dose of certain chemotherapy drugs (doxorubicin above 450 mg/m², or epirubicin above 900 mg/m²) during prior treatment
• People with uncontrolled imbalances in certain minerals in the blood, such as calcium, potassium, or magnesium
• People who have experienced certain serious heart or blood vessel events within the 6 months before randomisation, including heart attack, severe chest pain, significant heart rhythm problems, atrial fibrillation, bypass surgery, heart failure, stroke, mini-stroke, or serious blood clots in the lungs
• People with active inflammatory bowel disease, ongoing diarrhoea, short bowel syndrome, or a history of certain upper digestive tract surgeries including stomach removal
• People who have had another cancer diagnosis within the 5 years before randomisation, with the exception of certain treated skin cancers or cervical pre-cancers
• People with severe uncontrolled ongoing illness (for example, uncontrolled diabetes), a significant psychiatric condition, or abnormal test results that, in the treating doctor's judgement, would make participation unsafe or interfere with the trial results
• People who have had active suicidal behaviour in the past year or currently
• People who are pregnant or breastfeeding; women who could become pregnant must use effective non-hormonal contraception during treatment and for 90 days after stopping, and must have a negative pregnancy test before starting
• People who have had major surgery within 2 weeks before randomisation
• People for whom more than 10 weeks have passed since finishing radiotherapy and more than 16 weeks have passed since final surgery at the time of randomisation
• People who have previously received any CDK4/6 inhibitor treatment
• People who have taken, or are currently taking, strong medications known to significantly affect the way certain drugs are processed by the body (strong CYP3A4 inhibitors or inducers) within 7 days before randomisation
• People currently participating in another clinical trial involving an experimental drug, or who have done so within 30 days before randomisation

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