Phase 1 Breast 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 is hormone receptor-positive (ER and/or PR positive) and HER2-negative, with specific lymph node involvement or tumour size/grade combinations as determined by surgical biopsy (confirm with trial site for exact details)
• Adults aged 18 or older
• People who have had surgery to completely remove all detectable cancer, with clear margins (no cancer cells found at the edges of the removed tissue), at least 21 days before starting the trial
• People who have completed chemotherapy (either before or after surgery), with adjuvant chemotherapy finished at least 21 days before starting the trial
• People who have recovered from most side effects of chemotherapy and surgery (minor ongoing effects such as nerve tingling or hair loss may still be present)
• People whose blood counts, kidney function, and liver function meet the levels required by the trial, as confirmed by laboratory tests
• People whose heart rhythm and heart rate fall within the ranges required by the trial, as measured by an electrocardiogram (ECG)
• People who are able to swallow the study drug (Ribociclib) in tablet form
• People with a good general level of physical functioning, as rated on a standard medical scale (confirm with trial site)
• People for whom a stored tumour tissue sample from their surgery is available
• People who are willing and able to understand and sign the informed consent form
• Women who could become pregnant must have a confirmed negative pregnancy test within 14 days of starting the trial

Who may not be able to join:

• People who have previously had radiation therapy to the chest wall or nearby lymph node areas (radiation to other parts of the body may be acceptable)
• People who have previously been treated with a CDK4/6 inhibitor medication
• People who are currently pregnant or breastfeeding, or who are not willing to use adequate contraception throughout the trial
• People whose breast cancer has spread to distant parts of the body beyond the regional lymph nodes, or whose cancer has come back before enrolling
• People with significant or uncontrolled heart conditions, including a recent heart attack, angina, heart muscle disease, reduced heart pumping function, certain heart rhythm problems, or uncontrolled high blood pressure above a specific level
• People currently taking certain medications that affect heart rhythm (known to prolong the QT interval) that cannot safely be stopped or switched
• People with other serious or uncontrolled medical conditions that the trial investigator considers would make participation unsafe, or whose life expectancy is estimated at 5 years or less
• People with another active or recently treated invasive cancer (within the past 2 years), though certain treated skin cancers or cervical cancer in situ may still be eligible (confirm with trial site)
• People with significant digestive system problems that could affect how the oral study medication is absorbed
• People who would need to take other anti-cancer or experimental treatments during the trial period
• People currently taking certain medications, herbal supplements, or consuming certain fruits (such as grapefruit, star fruit, or Seville oranges) known to interfere with how the study drug is processed by the body, within 7 days before joining the trial

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