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 able to understand the study and provide written consent to participate
• Adults aged 18 or older
• People who have been diagnosed with a specific type of breast cancer (hormone receptor-positive, HER2-negative) that has spread to other parts of the body, and whose cancer has stopped responding to at least one round of chemotherapy
• People whose doctor considers them suitable for the chemotherapy treatment used in the comparison group of this trial
• People who have at least one area of cancer that can be measured on scans, according to standard medical guidelines
• People who are reasonably well and able to carry out daily activities, based on a standard health assessment scale (scoring 0 or 1 out of 5)
• People with an expected survival of at least 12 weeks
• People whose liver, kidneys, bone marrow, and other organs are functioning well enough to participate
• Women who could become pregnant, and men whose partners could become pregnant, who are willing to use reliable contraception from the time of signing consent until 180 days after the last dose of the study treatment

Who may not be able to join:

• People who have received chemotherapy, targeted therapy, immunotherapy, or other cancer treatments within the 4 weeks before starting the trial
• People who still have significant side effects (above a mild level) from previous cancer treatments
• People who have had major surgery within 4 weeks before starting the trial, or who are expected to need major surgery during the trial
• People who have previously received a type of cancer treatment called a topoisomerase I inhibitor (including certain antibody-drug combination therapies), or any treatment targeting a protein called TROP2, or who have taken any other experimental cancer drug within 28 days (or within 5 half-lives of that drug) before starting the trial
• People who have had a blood clot, bowel blockage, gastrointestinal bleeding, or a hole in the gut within the past 6 months
• People with an uncontrolled bacterial, viral, or fungal infection
• People who have brain or spinal cord metastases that are causing symptoms, have not been treated, or still require ongoing treatment
• People who have a cancer that started in the brain or spinal cord, or who have had another type of cancer within the past 3 years
• People with other serious uncontrolled health conditions
• People with significant stomach or bowel conditions (such as chronic gastritis, chronic bowel inflammation, or stomach ulcers), or a history of severe or long-lasting diarrhoea
• People with significant heart or blood vessel disease
• People living with HIV
• People with active hepatitis B or hepatitis C
• People with a known allergic reaction to irinotecan or similar medicines (such as topotecan), or who have had a severe (grade 3 or higher) gut reaction to irinotecan previously, or who are allergic to any ingredient in the trial drug
• Women who are pregnant or breastfeeding

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