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 information and are willing to sign a written consent form and follow the study schedule and procedures
• Women between 18 and 70 years of age (inclusive)
• People with a laboratory-confirmed diagnosis of breast cancer that cannot be surgically removed, has spread locally, or has spread to other parts of the body, and whose cancer tests negative for estrogen receptor (ER), progesterone receptor (PR), and HER-2 (commonly called triple-negative breast cancer)
• People who have not previously received systemic drug treatment (other than hormone therapy) for advanced breast cancer, OR people who did receive taxane-based chemotherapy before or after surgery, as long as the cancer came back or spread at least 12 months after that treatment ended
• People whose general physical functioning is rated 0 or 1 on a standard medical activity scale, meaning they are fully active or have only minor limitations in physical activity
• People with a life expectancy of at least 12 weeks
• People who have at least one tumour that can be measured on a scan according to standard criteria (confirm with trial site for specific details about which lesions qualify)

Who may not be able to join:

• People who have previously been treated with certain immune-boosting or immune-checkpoint drugs (such as CTLA-4, PD-1, PD-L1, or LAG3 inhibitors, or CD137 agonists), or with drugs that target blood vessel growth (anti-VEGF therapies)
• People who have brain or spinal cord metastases that are not controlled or are causing symptoms
• People who have had another active cancer within the past 5 years, unless that cancer was treated locally and is considered fully cured
• People with poorly controlled high blood pressure (readings of 140 mmHg or higher for the top number, and/or 90 mmHg or higher for the bottom number)
• People with a history of a hypertensive crisis or a condition called hypertensive encephalopathy (a severe complication of very high blood pressure)
• People who have had an abnormal passage or hole in the abdomen, between the throat and oesophagus, in the digestive system, or an internal abdominal infection within the past 6 months
• People who still have side effects from previous cancer treatments that have not reduced to a mild level or resolved, based on standard medical grading criteria
• People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled
• People who have previously received a stem cell transplant from a donor or an organ transplant

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