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:

• People who have been diagnosed with triple negative breast cancer (TNBC), confirmed by a laboratory test, according to the most recent standard medical guidelines.
• People whose TNBC has not spread beyond the breast area, and whose tumor is either 2 centimetres or larger, or whose cancer has reached nearby lymph nodes with a tumor of at least 1 centimetre.
• People who have not yet received any treatment for this breast cancer — including no surgery on the breast, no radiation therapy, and no chemotherapy.
• People whose health is suitable for receiving the chemotherapy drugs used in this study, specifically paclitaxel and carboplatin.
• People who are willing and able to provide blood samples at specific points during the study.
• People who are willing and able to have a needle biopsy of their tumor before treatment begins.
• People aged 18 or older.
• People who are generally well enough to carry out daily activities, with only minor symptoms at most (this is measured using a standard medical scale called ECOG, scores 0–1).
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (confirm specific values with the trial site).
• People who are able to use reliable contraception before, during, and for 6 months after completing treatment — this applies to anyone who could become pregnant or father a child. Anyone who becomes pregnant or suspects pregnancy during the study must tell their treating doctor immediately.
• People who are able to understand the study and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

• People who have received chemotherapy or radiation within 4 weeks before joining, or any prior treatment aimed at treating this breast cancer.
• People who are currently taking part in another clinical trial using an experimental treatment.
• People whose cancer has spread to distant parts of the body (Stage IV disease).
• People who have a condition that weakens the immune system, or who have been taking steroid or immune-suppressing medication within 7 days before the first dose — though people on a low, stable long-term steroid dose (equivalent to 10mg or less of prednisone for more than 4 weeks) may still be eligible (confirm with trial site).
• People who have an active autoimmune disease that required systemic medical treatment in the past year. People who take hormone or gland replacement therapies (such as thyroid medication or insulin) are not excluded on this basis.
• People whose overall health condition, in the treating doctor's opinion, could interfere with the trial or make participation not in their best interest.
• People who have had a serious allergic reaction to any of the drugs used in this study — carboplatin, paclitaxel, dupilumab, or pembrolizumab — or to similar types of medications, including biological therapies such as monoclonal antibodies or vaccines.
• People who are HIV positive with a detectable viral load, not on a stable HIV treatment regimen, or with low immune cell counts below a certain level.
• People with currently active Hepatitis B or Hepatitis C infection. People with Hepatitis B that is well controlled on antiviral medication and with undetectable virus levels may still be considered eligible (confirm with trial site).
• People with a known active parasitic worm (helminth) infection that has not been treated. People who were previously treated and fully recovered may still be eligible.
• People who have had a bone marrow transplant or a solid organ transplant.
• People who have received a live vaccine within 30 days before the planned start of treatment.
• People who previously had a serious immune-related side effect from immunotherapy that has not fully resolved or improved to a mild level.
• People with a history of certain serious lung conditions, such as pulmonary fibrosis or inflammation of the lung tissue linked to prior cancer immunotherapy that required high-dose steroid treatment. This also includes a history of radiation-related lung inflammation treated with steroids.
• People with serious uncontrolled health conditions, such as active infection, heart failure, unstable chest pain, irregular heart rhythm, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People who are currently pregnant or breastfeeding, due to potential risks to the baby.

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