Phase 2 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:

• People aged 18 or older
• People whose general health and ability to carry out daily activities meets a certain level of functioning (confirm with trial site)
• People whose life expectancy is more than 3 months
• People with a laboratory-confirmed diagnosis of metastatic triple negative breast cancer, meaning the cancer tests negative for estrogen receptor, progesterone receptor, and HER2 (with receptors below 10%), as determined using standard testing guidelines
• People whose cancer has gotten worse after 1 to 2 previous treatments (such as chemotherapy or a drug-antibody combination) given for metastatic disease
• People who have measurable or trackable cancer that can be assessed using standard imaging criteria, including areas that were previously treated with radiation if the cancer has since grown there
• People who have recovered from most side effects of previous cancer treatment (hair loss is an exception), with any remaining side effects at or below a mild level
• For the Phase 2 part of the trial only: people whose cancer tests negative for a protein called PD-L1 (for the earlier Phase 1 safety portion, any PD-L1 result is acceptable)
• People whose blood counts and organ function results fall within the ranges required by the trial (confirm specific values with trial site), including adequate levels of white blood cells, platelets, haemoglobin, liver function markers, kidney function, and heart function
• People whose haemoglobin levels meet the required threshold without recent blood transfusions or the use of red blood cell stimulating medication in the past two weeks
• People whose heart pumping function (left ventricular ejection fraction) is at or above 50% on a heart ultrasound
• Women who could potentially become pregnant must have a negative pregnancy test before joining
• Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose, and must not donate sperm during this time
• Female participants must not be pregnant or breastfeeding, and must either be unable to become pregnant or agree to use effective contraception during the study and for 120 days after the last dose
• People who are willing and able to give written informed consent and follow the study requirements

Who may not be able to join:

• People with an immune system disorder, or who are taking steroid medication above a certain daily dose, or any other immune-suppressing medication within 7 days before the first dose
• People who have received chemotherapy, radiation, biological therapy, or immunotherapy within 28 days before starting the trial
• People who have previously received immune checkpoint inhibitor therapy for metastatic disease (prior use in an earlier treatment setting may be permitted if the last dose was at least 1 year before starting the trial — confirm with trial site)
• People who have had radiotherapy within 2 weeks before starting the trial, or who have not recovered from radiation side effects, or who still need steroids related to radiation, or who have had radiation-related lung inflammation
• People who have received a live vaccine (such as those for measles, mumps, chickenpox, yellow fever, or rabies) within 30 days before the first dose (most standard injected flu vaccines are allowed, but nasal spray flu vaccines are not)
• People currently taking warfarin (certain other blood-thinning medications are allowed — confirm with trial site)
• People who have taken part in another clinical trial or used an experimental device within 4 weeks before the first dose
• People who have difficulty swallowing tablets or capsules, or who have problems absorbing medication, or who are experiencing ongoing nausea or vomiting
• Women who are pregnant, planning to become pregnant, or currently breastfeeding
• People with a known allergy to any ingredient in the study medications
• People with a current or recent additional cancer diagnosis, with some exceptions (such as certain treated skin cancers, early-stage cancers now in full remission, or cancers from which the person has been cancer-free for at least three years — confirm with trial site)
• People with active, untreated cancer spread to the brain or the lining of the brain (people with previously treated and stable brain metastases may be eligible if they meet specific stability and steroid-free criteria — confirm with trial site)
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People with an active infection that requires treatment with medication
• People with a known history of HIV infection
• People with known active Hepatitis B or Hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People with another ongoing or past medical condition that the trial doctor considers would increase the risk of participating
• People with any condition, treatment history, or test result that the trial doctor believes could affect the study results or make participation unsafe or unsuitable
• People with known psychiatric conditions or substance use disorders that could interfere with following the trial requirements
• People who are pregnant, breastfeeding, or planning to conceive or father children during the study period and for 120 days after the last dose
• People who have had an organ or tissue transplant from another person
• People with significant heart problems, including a history of moderate-to-severe heart failure, unstable chest pain, a heart attack, stroke within the past 6 months, or a heart rhythm disorder requiring treatment
• People with more than a low level of protein detected in the urine, unless a more detailed test shows the amount is within an acceptable range
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years (hormone or gland replacement therapies are generally not considered systemic treatment and are typically allowed — confirm with trial site)
• People with any other condition that the trial doctor considers would make participation unsafe

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