Early Phase 1 Breast Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are a woman aged 18 or older
• You have been diagnosed with triple-negative breast cancer (a specific type of breast cancer) that has spread to other parts of the body, and you have previously received certain standard chemotherapy drugs (unless those drugs were not medically suitable for you)
• You have not received more than 3 chemotherapy treatment plans for your cancer after it spread
• Your cancer that has spread is located in areas such as the breast, chest wall, nearby lymph nodes, lungs, or liver, where a tissue sample (biopsy) can be safely taken — or a skin biopsy may be used instead (confirm with trial site)
• You are generally able to carry out daily activities with little or no limitation (this is measured by a standard medical scale called ECOG 0–1; confirm with trial site)
• Your blood cell counts are at safe enough levels, as shown by recent blood tests
• Your liver is working well enough, as shown by blood test results within acceptable ranges
• Your kidneys are working well enough, as shown by blood test results within acceptable ranges
• Your blood clotting is working well enough, as shown by blood test results within acceptable ranges
• If you have had cancer spread to the brain in the past, it has been treated, you have been off steroids for at least 2 weeks, you have no ongoing need for steroid or anti-seizure medicines, and there is no sign the brain tumours are growing
• You are able to attend appointments for treatment and follow-up
• You are able to understand the study and sign a consent form agreeing to take part

Who may not be able to join:

• You have received a live vaccine (such as the nasal flu spray FluMist®) within the last 30 days
• You have an active autoimmune disease (where your immune system attacks your own body) that has needed medical treatment in the past 2 years — note that simple hormone or supplement replacement therapy does not count as this type of treatment
• You have an immune system condition, or you are currently taking steroid tablets above a low daily dose, or other medicines that suppress your immune system
• You have a known history of HIV
• You have a known history of Hepatitis B or currently active Hepatitis C infection
• You have a history of lung inflammation (not caused by infection) that needed steroid treatment, or you currently have lung inflammation
• You have significant nerve damage or pain in your hands or feet (called peripheral neuropathy, grade 2 or higher — confirm with trial site)
• You have finished radiotherapy for your cancer less than 2 weeks before starting the trial
• You currently have an active infection that requires treatment with medicines
• You have had a serious heart problem in the last 6 months, such as a heart attack, or you have moderate-to-severe heart failure
• You have a known history of active tuberculosis (TB)
• You are pregnant or breastfeeding — and all participants who could become pregnant must use effective contraception from the start of the study until at least 3 months after the last dose of the study drug
• You have severe lung problems affecting your breathing or oxygen levels at rest
• You have serious liver disease, such as cirrhosis or severe liver failure
• You have received other cancer treatments or been in another clinical trial within the last 4 weeks
• You are currently receiving any other cancer treatment or taking part in another clinical trial at the same time
• You currently have another active cancer

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