Early Phase 1 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:

• Women aged 18 or older
• People who have been diagnosed with metastatic triple-negative breast cancer (a type of breast cancer that lacks three common receptors) and have previously been treated with standard chemotherapy drugs (anthracycline, cyclophosphamide, and taxane), unless there was a medical reason those drugs could not be used
• People who have received no more than 4 prior chemotherapy treatment courses for their metastatic disease (those with more than 4 prior courses may still be considered at the treating doctor's discretion, if overall health status is good)
• People who have cancer that has spread to areas such as the breast, chest wall, nearby lymph nodes, lungs, or liver in a way that allows a tissue sample (biopsy) to be safely taken — if not, a skin biopsy or other arrangement may be considered at the doctor's discretion
• People whose general health and ability to carry out daily activities meets a specific standard (rated 0 or 1 on a medical scale used in clinical trials)
• People whose blood cell counts are within acceptable ranges, including white blood cells, platelets, and red blood cells (confirm with trial site for specific values)
• People whose liver function test results are within acceptable ranges (confirm with trial site for specific values)
• People whose kidney function is within an acceptable range (confirm with trial site for specific values)
• People who have had brain metastases (cancer that spread to the brain) in the past, provided the brain metastases have been treated, are not currently progressing, and steroid or anti-seizure medications are no longer needed
• People who are able to attend treatment sessions and follow-up appointments
• People who are able to understand the nature of the study and provide written consent to participate

Who may not be able to join:

• People who have received a live or live-attenuated vaccine within 30 days before starting the trial treatment (non-live/killed vaccines are permitted)
• People who have nerve damage in their hands or feet (peripheral neuropathy) that is moderate or severe in nature
• People who have completed radiation therapy for metastatic disease less than 2 weeks before starting the trial treatment
• People who currently have an active infection that requires treatment with systemic (whole-body) medications
• People with significant heart conditions, such as a heart attack, acute coronary syndrome, or heart bypass/stenting procedure within the past 6 months, or moderate-to-severe heart failure
• People with a known history of active tuberculosis
• People who are currently pregnant or breastfeeding; also, people who are able to become pregnant must agree to use effective contraception from the start of the study until at least 3 months after the last dose of the study drug
• People with severely reduced lung function or low oxygen levels at rest
• People with serious liver disease, such as cirrhosis or severe liver impairment
• People whose treating doctor considers participation not to be in their best interest, or who have a condition that could interfere with the study results or their ability to participate fully
• People who have received any systemic cancer treatment within 2 weeks before starting the trial treatment
• People who have received any other experimental (investigational) treatment within 4 weeks before starting the trial (or within 4 weeks for certain antibody-based therapies)
• People who would be receiving any other experimental or cancer treatment at the same time as this trial
• People who currently have another active cancer diagnosis

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