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 18 years of age or older
• People who have signed a consent form agreeing to take part in the study
• People who have a confirmed breast cancer diagnosis with disease that has either come back in a location that cannot be surgically removed, or has spread to other parts of the body, and who have already tried multiple previous treatments appropriate to their cancer type (the specific number and types of prior treatments required depend on the cancer's characteristics, such as HER2 status, hormone receptor status, or triple negative status — confirm details with the trial site)
• People whose breast cancer has spread to the brain, provided the brain disease has been stable on imaging for at least 4 weeks before the first dose, no steroids have been needed for at least 2 weeks before the first dose, the tumour is not pressing on certain critical brain areas, and if surgery was performed, at least 3 weeks have passed and the wound has healed
• People whose doctors expect them to survive for at least 4 months
• People with a general health and activity level rated at 0, 1, or 2 on the ECOG scale, which means people who are fully active, have some limitations but can care for themselves, or are capable of self-care but unable to do active work (confirm with trial site)

Who may not be able to join:

• People who have had chemotherapy, immunotherapy, or major surgery within the 21 days before the first dose
• People who have had radiation therapy within 14 days before the first dose
• People who still have side effects from previous treatments that have not returned to mild or baseline levels (exceptions apply for hair loss and mild anaemia not requiring transfusions)
• People who had a severe (grade 3 or higher) reaction to a prior checkpoint inhibitor therapy, unless it has been successfully treated and managed
• People with ongoing side effects from a prior checkpoint inhibitor that have not settled to mild levels, except for stable hormone-related conditions that are not causing symptoms
• People with a history of serious allergic reactions to the treatments used in this study, including to beef or to components used in preparing the study vaccine SV-BR-1-GM
• People whose kidney function blood tests fall outside acceptable ranges as defined by the trial (confirm specific values with trial site)
• People whose blood counts are too low — specifically, white blood cell, platelet, or haemoglobin levels below the trial's minimum thresholds (confirm specific values with trial site)
• People whose liver function tests are outside acceptable levels, including bilirubin, alkaline phosphatase, and liver enzymes ALT/AST — stricter limits apply for people whose cancer has spread to the liver (confirm specific values with trial site)
• People whose blood clotting test results are outside acceptable ranges, unless they are already on blood-thinning medication and their levels are within the intended treatment range
• People taking any medications listed as prohibited in the trial protocol (confirm with trial site)
• People with too much protein in their urine on testing
• People with certain abnormal heart rhythm findings on an ECG, including a specific heart rhythm measurement (QTc interval) consistently above 480 milliseconds
• People with advanced heart failure classified as stage 3 or 4 by the New York Heart Association scale
• People with a moderate or severe fluid build-up around the heart
• People with fluid around the lungs or in the abdomen that is causing symptoms — people who have been treated and are now stable may still be considered eligible
• Women who could become pregnant, unless they agree to use appropriate contraception during the study and have a negative pregnancy blood test within 7 days before starting treatment
• Men who are capable of fathering a child, unless they agree to use appropriate contraception for the duration of the study
• Women who are currently pregnant or breastfeeding
• People with another cancer that is currently active or being treated, or who have had another cancer within the past 2 years — exceptions exist for certain low-risk or cured skin cancers and a small number of other conditions (confirm with trial site)
• People with uncontrolled HIV infection or signs of AIDS
• People with a diagnosed immune system deficiency, or who are taking steroid medications at doses above 10 mg of prednisone (or equivalent) daily, or other immune-suppressing treatments within 7 days before the first dose
• People with an active autoimmune disease that has needed medical treatment within the past year — hormone replacement and similar therapies are generally permitted (confirm with trial site)
• People with known active Hepatitis A, B, or C infection, based on specific blood test results (confirm with trial site)
• People with an active infection requiring antibiotic or other systemic treatment within the past 14 days
• People with severe psychiatric conditions such as schizophrenia, bipolar disorder, or borderline personality disorder, or other serious ongoing medical problems, unless specifically approved by the treating doctor in consultation with the trial's medical team
• People who have received a live vaccine within 28 days before the first dose
• People who are already taking part in another clinical trial, unless specifically approved by the investigator

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