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:

• People aged 18 or older who are able to understand, sign, and date a consent form before any study procedures begin.
• People who have been diagnosed with breast cancer that has spread to other parts of the body or cannot be surgically removed.
• People whose breast cancer has tested negative for HER2, estrogen receptor, and progesterone receptor (sometimes called "triple-negative" breast cancer) based on specific lab test results.
• People whose tumor has been tested for a protein called PD-L1, regardless of what the result showed, using a specific approved test.
• People who have received up to one prior chemotherapy treatment (with or without immunotherapy) for their metastatic disease — or whose cancer came back within six months of completing earlier chemotherapy, which would count as that one prior treatment.
• People who have previously received immune checkpoint inhibitor therapy (a type of immunotherapy) combined with chemotherapy, either before/after surgery or for metastatic disease.
• People who have previously received certain targeted therapies (such as olaparib) — these do not count toward the chemotherapy limit.
• People whose cancer has progressed or worsened during or after their most recent treatment, or who were unable to tolerate that treatment.
• People who have a stored tumour tissue sample less than 3 years old available for testing, or who are willing to have a new biopsy taken at enrolment if no suitable sample is available.
• People with or without measurable tumour lesions visible on scans.
• People with a good general health and activity level (rated 0 or 1 on a standard scale used by doctors to measure how cancer affects daily functioning).
• People whose heart is pumping blood at a healthy level (at least 50% efficiency), confirmed within the 6 months before joining.
• People whose recent blood test results meet the specific levels required by the trial (confirm with trial site for exact values).
• People who meet the trial's contraception and pregnancy requirements, including (where applicable): using highly effective contraception from screening until at least 7 months after the last dose of study treatment; not breastfeeding during the study or for 7 months after the last dose; not donating or using stored eggs during the study or for 7 months after the last dose (egg preservation before joining may be considered); male participants using a condom from screening until 5 months after the last dose if sexually active with a partner who could become pregnant; male participants not donating sperm or attempting to father a child during the study or for 5 months after the last dose (sperm preservation before joining may be considered).

Who may not be able to join:

• People who are currently pregnant or breastfeeding.
• People who are able to have children or father a child and are unwilling to use effective contraception as required by the trial.
• People who have another active cancer from a different primary tumour that has spread.
• People who have had unstable chest pain (angina), a heart attack, or heart failure in the 6 months before joining, or who have a significant ongoing heart rhythm problem requiring medication (stable atrial fibrillation is generally acceptable).
• People with a history of inflammation of the heart muscle (myocarditis).
• People with significant breathing problems, such as a serious or moderate ongoing lung condition, present within the 6 months before joining.
• People who have a history of non-infectious lung inflammation that required steroid treatment for more than 28 days in a row, or who currently have lung inflammation of this type.
• People who have had a hole (perforation) in their digestive tract within the 6 months before joining.
• People who currently have an uncontrolled infection that requires ongoing treatment through a drip (intravenous antibiotics, antivirals, or antifungals).
• People with HIV and a detectable amount of virus in their blood, or a very low immune cell count, or who have active hepatitis B or C infection.
• People who have an active autoimmune, connective tissue, or inflammatory condition that required immune-suppressing or steroid treatment in the two years before joining — though some conditions may still be eligible (such as well-controlled type 1 diabetes, thyroid conditions managed with medication only, or skin conditions like vitiligo or psoriasis that do not need systemic treatment) (confirm with trial site).
• People who currently have untreated pressure on the spinal cord.
• People who have brain metastases (cancer spread to the brain) that are currently causing symptoms or that require steroid medication to manage symptoms.
• People who still have significant side effects from previous cancer treatments that have not yet returned to a mild level or to their pre-treatment baseline (hair loss is an exception; some ongoing moderate side effects may still be considered — confirm with trial site).
• People who have had a serious allergic reaction to any of the drugs used in this trial, or to similar antibody-based medicines.
• People who have previously been treated with a drug called relatlimab, any other LAG-3 targeting treatment, sacituzumab govitecan (SG), or any other TROP2-targeted antibody-drug treatment.
• People whose personal, social, or geographical circumstances would, in the investigator's judgement, create safety risks or make participation difficult.
• People who have not waited long enough after their last treatment before starting the trial (confirm with trial site for required waiting periods).

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