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 18 or older
• People who have been diagnosed through laboratory testing with triple negative breast cancer (a specific type of breast cancer) that cannot be removed by surgery or has spread to other parts of the body, with no curative treatment options available
• People who have not had chemotherapy, radiation therapy, or major surgery in the 4 weeks before starting the trial treatment
• People whose cancer stopped responding to a combination of chemotherapy and a specific immunotherapy drug (pembrolizumab), and whose doctor believes they can continue receiving that immunotherapy
• People who agree to have a tissue sample (biopsy) taken before treatment and again 6 weeks after treatment starts (for the first part of the study), with the pre-treatment biopsy taken at least 4 weeks after their last chemotherapy
• People who are able to use adequate contraception during the study, if there is any possibility of becoming pregnant; anyone who becomes pregnant or suspects pregnancy during the study must inform their treating doctor immediately
• People with a general health and activity level rated at 0 or 1 on a standard medical scale, meaning they are either fully active or have minor limitations but can carry out light activity (confirm with trial site)
• People whose recent blood test results meet these levels: platelet count at or above 100,000/uL, haemoglobin at or above 9.0 g/dL, neutrophil count at or above 1,500/uL, total bilirubin within the normal range for the testing laboratory, liver enzymes (AST and ALT) no higher than 2.5 times the normal range, kidney function (creatinine clearance) at or above 50 mL/min, and a blood sugar control marker (HbA1c) at or below 8.5
• People who have measurable cancer that can be tracked using standard imaging criteria
• People who are able to swallow and keep down oral (tablet or capsule) medication
• People who understand the experimental nature of the study and sign a written consent form approved by an ethics committee before any study-related procedures begin

Who may not be able to join:

• People currently taking medicines that suppress the immune system, including steroids, unless at least 3 weeks have passed since stopping those medicines
• People with an active autoimmune disease requiring ongoing immune-suppressing treatment, or a history of an organ transplant
• People whose cancer is growing rapidly or causing significant symptoms
• People whose cancer did not respond at all to the initial combination of chemotherapy and pembrolizumab, with the cancer continuing to grow within the first 12 weeks of that treatment
• People who are pregnant or currently breastfeeding; people who could become pregnant will need to have a pregnancy test during screening
• People who have brain metastases (cancer that has spread to the brain) causing symptoms and who received radiation treatment for them less than 4 weeks before joining the trial
• People who have had another cancer (other than breast cancer) within the past 5 years, except for certain cancers considered to carry very little risk of spreading or causing death (confirm with trial site)
• People with uncontrolled ongoing illness, including active infection, unstable heart conditions, uncontrolled heart failure, irregular heart rhythms, or mental health or personal circumstances that would make it difficult to follow the study requirements
• People who are unwilling or unable to follow the trial's requirements
• People for whom a type of medication called beta-blockers would not be safe, including those with: uncontrolled depression, unstable chest pain (angina), severe heart failure, low blood pressure (systolic below 100 mmHg), severe asthma or chronic lung disease (COPD), poorly controlled diabetes (HbA1c above 8.5 or fasting blood sugar above 160 mg/dL at screening), certain circulation problems in the limbs (peripheral arterial disease or Raynaud's syndrome), an untreated adrenal gland tumour (pheochromocytoma), or people already taking beta-blockers or a related type of heart/blood pressure medication (non-dihydropyridine calcium channel blockers)
• People who the trial investigators consider unsuitable for any other reason

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