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 who have been diagnosed with locally advanced breast cancer affecting the chest wall, where lab testing has confirmed the tumour is positive for a marker called PDL1 and/or contains immune cells called tumour infiltrating lymphocytes (TILs), and who have previously received chemotherapy or radiation therapy (with or without cancer that has spread to other parts of the body).
• People whose breast cancer has spread to the skin only (with or without a visible primary tumour) may also be considered.
• People who have a part of their tumour that can be safely sampled multiple times during the trial.
• People with a life expectancy of more than 3 months.
• People aged 18 or older at the time of signing the consent form.
• People — female or male — diagnosed with a specific type of breast cancer that has spread along the chest wall in a particular pattern (called lymphangitic spread), with hormone receptor and HER2 status already determined.
• People who are able and willing to provide a fresh tumour tissue sample (biopsy) for testing, and whose sample is confirmed as adequate by the central laboratory.
• People who have measurable disease that can be tracked on scans, as assessed by a central radiology review.
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1), assessed within 10 days of starting treatment.
• Female participants of childbearing potential who are willing to use an approved method of contraception throughout the study and for 120 days after the last dose of the study medicine (abstinence is acceptable if that is their usual and preferred method).
• Male participants of childbearing potential who agree to use an approved method of contraception from the first dose through to 120 days after the last dose (abstinence is acceptable if that is their usual and preferred method).
• Female participants of childbearing potential who have a negative pregnancy test (urine or blood) within 72 hours before the first dose of study medicine.
• People with hormone receptor-positive or HER2-positive breast cancer, where their disease is considered no longer responding to hormone therapy or HER2-targeted treatment, and where no further such treatment is appropriate.
• People whose blood test results show that their organs (such as liver, kidneys, and bone marrow) are functioning adequately, tested within 10 days of starting treatment.

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an experimental treatment, or who have received an experimental treatment or device within the past 4 weeks.
• People who have been diagnosed with an immune system deficiency, or who are currently receiving steroid treatment or other medicines that suppress the immune system within 7 days before the first dose.
• People with a known history of active tuberculosis (TB).
• People who have a known allergy or sensitivity to the study drug (pembrolizumab) or any of its ingredients.
• People who have received a type of cancer treatment called a monoclonal antibody within 4 weeks before the trial start date, or who have not yet recovered from side effects of such treatment.
• People who have received chemotherapy, targeted therapy, or radiation therapy within 2 weeks before the trial start date, or who have not yet recovered from side effects (note: people with mild nerve-related side effects may still be considered — confirm with trial site; people who have had major surgery must have adequately recovered before starting).
• People who have another cancer that is currently growing or requires active treatment (with the exception of certain treated skin cancers or early-stage cervical cancer).
• People who have active cancer spread to the brain or the lining around the brain (carcinomatous meningitis). People with previously treated and stable brain metastases, who are not on steroids and show no signs of new growth for at least 4 weeks, may still be considered — but carcinomatous meningitis is excluded regardless.
• People who have an autoimmune disease that has required systemic medical treatment in the past 2 years (routine hormone replacement therapies, such as thyroid or insulin, are not considered a reason for exclusion).
• People with a known history of, or currently active, non-infectious lung inflammation (pneumonitis).
• People who have an active infection that requires treatment through the bloodstream (systemic therapy).
• People who have a medical condition, ongoing treatment, or abnormal test result that the treating doctor believes could affect the trial results or make participation unsafe.
• People with known mental health conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and for 120 days after the last dose.
• People who have previously received certain types of immunotherapy medicines that target the PD-1 or PD-L1/PD-L2 pathways (a specific class of cancer treatment).
• People with a known history of HIV.
• People with known active Hepatitis B or Hepatitis C infection.
• People who have received a live vaccine within 30 days before the planned start of treatment (most standard injected flu vaccines are allowed; nasal spray flu vaccines are not).

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