Phase 2 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:

• You are willing and able to sign a consent form agreeing to take part in the study
• You are 18 years old or older, of any gender, race, or ethnic background
• You have been diagnosed with locally advanced or metastatic breast cancer that is ER-positive and HER2-low (a specific low level of HER2 protein, confirmed by lab tests), including cases where surgery is not possible and treatment is focused on managing the disease
• You have previously been treated with hormone-based therapy together with a type of drug called a CDK4/6 inhibitor for advanced or metastatic disease
• You have had at least one round of chemotherapy, and your most recent treatment before joining this trial was a drug called trastuzumab deruxtecan (T-DXd)
• Your tumour can be safely biopsied (a small tissue sample taken) using image-guided procedures
• If you could become pregnant, you have a negative pregnancy test within 14 days before starting the trial and agree to use medically approved contraception during the study and for 12 weeks after the last dose
• Your cancer can be measured or assessed by CT or MRI scan
• You are reasonably active and able to care for yourself (confirm with trial site regarding specific activity level assessment)
• Your doctors expect you to live for at least 3 months or longer
• Your blood counts, kidney function, and liver function meet certain minimum levels as confirmed by blood tests (confirm with trial site for specific values)
• If you have cancer that has spread to the brain, it must be stable and well-controlled for at least 4 weeks before starting treatment, meaning it is no longer causing symptoms or requiring high doses of steroid medication

Who may not be able to join:

• You are currently taking part in another medical research study that may conflict with this one
• You have a known allergy or sensitivity to the study drug (sacituzumab govitecan/SG), irinotecan, or a related substance called SN-38
• You would not be available for follow-up appointments during the study
• You are not willing to consider systemic (whole-body) drug treatments
• Your tumour cannot be safely biopsied
• You still have significant side effects from previous cancer treatments that have not cleared up (with some exceptions that your doctor can assess)
• You currently have another active cancer (though a history of cancer that has been fully treated with no signs of return for at least 3 years, or certain low-risk, surgically removed cancers, may be allowed)
• You have active, untreated cancer that has spread to the brain (previously treated and now stable brain metastases may still be allowed — confirm with trial site)
• You are currently pregnant or breastfeeding
• Your blood, kidney, or liver function results do not meet the required levels
• You have an ongoing condition causing uncontrolled diarrhoea, a chronic inflammatory bowel disease, or have had a serious bowel tear/rupture within the past 6 months
• You currently have a serious active infection that requires antibiotic treatment

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