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 between 18 and 75 years old
• People who are willing to take part in the study voluntarily
• People whose breast cancer has been confirmed by a tissue sample (biopsy) to be triple-negative breast cancer (meaning the cancer tests negative for HER2, oestrogen receptors, and progesterone receptors) and cannot be removed by surgery, has spread locally, or has spread to other parts of the body
• People who have not yet received any systemic (whole-body) anti-cancer treatment for their advanced or metastatic triple-negative breast cancer
• People who received anti-cancer treatment before surgery or after surgery (neoadjuvant or adjuvant therapy) may still be considered, provided that at least 6 months passed between the end of that treatment and the cancer returning or spreading; for one specific treatment arm in the trial, if a taxane drug was used before or after surgery, at least 12 months must have passed before the cancer returned or spread (confirm with trial site)
• People whose major organs (such as liver, kidneys, and bone marrow) are functioning adequately
• People with a general health and activity level rated as 0 or 1 on a standard medical scale, meaning they are either fully active or have minor limitations but are able to carry out light work
• People with a life expectancy of at least 12 weeks
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines (RECIST v1.1)

Who may not be able to join:

• People with brain or spinal cord (central nervous system) cancer spread that has not been treated or is currently active
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen
• People whose tumour is wrapping around major blood vessels, or where there is significant tissue breakdown in the tumour that could raise the risk of bleeding
• People with a history of significant bleeding problems or serious blood clotting disorders
• People with high blood pressure that is not well controlled
• People who have an active autoimmune disease (where the immune system attacks the body) that has required ongoing whole-body treatment within the 2 years before starting the trial
• People with a history of a lung condition called interstitial lung disease, or who have previously been treated with steroids for non-infectious lung inflammation, or who show signs of active lung inflammation on a scan taken during the screening period
• People with certain eye conditions, including severe dry eyes, inflammation of the eye surface, severe exposure-related eye damage, or other significant eye disorders (confirm with trial site)
• People with serious heart or cardiovascular disease
• People who have had a serious infection (rated above Grade 2 on a standard medical severity scale) within 28 days before starting the trial
• People who previously received certain immune-based cancer treatments (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar drugs targeting the immune system) as part of before- or after-surgery treatment may still be considered if at least 6 months have passed since treatment ended; however, people who have previously received certain antibody-drug treatments that target a protein called Nectin-4 or carry a component called MMAE (such as Enfortumab Vedotin) are not eligible
• People who have had a different type of cancer diagnosed within the 5 years before starting the trial
• People who the trial doctor considers unsuitable for the study treatment for any other medical reason

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