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:

• Adults aged 18 or older, of any gender.
• People whose general health and ability to carry out daily activities falls within a specific range measured by a standard oncology scale (ECOG score of 0 or 2).
• People who have been diagnosed with triple-negative breast cancer (TNBC), confirmed through a tissue sample, meeting specific hormone receptor and HER2 testing thresholds as defined by established medical guidelines.
• People whose primary breast tumour can be measured by ultrasound and is at least 1 cm in size.
• People for whom a doctor has determined it is appropriate to receive a standard pre-surgery treatment combination including pembrolizumab and chemotherapy (such as the Keynote-522 regimen), with the goal of curing the cancer.
• People with cancer present in more than one area of the breast (multifocal or multicentric disease), provided additional testing is carried out as required by standard medical practice.
• People who have not received any prior treatment of any kind for their TNBC.
• People who are willing to undergo regular ultrasound scans, repeat tissue biopsies, and blood tests throughout the trial.
• People whose blood test results show that their organs (including kidneys, liver, bone marrow, and thyroid) are functioning at a level that meets the trial's required thresholds, with tests taken within 28 days before starting treatment (and thyroid tests within 14 days).
• People who are able and willing to use highly effective contraception methods (those with a failure rate of less than 1% when used correctly and consistently) from at least 28 days before starting treatment until 4 months after the last dose — this applies to people who are capable of becoming pregnant or of causing a pregnancy.
• Women who are capable of becoming pregnant must have a negative pregnancy test (urine or blood) within 72 hours before starting treatment.
• People whose tumour biopsy shows at least 1% immune cell activity in the surrounding tissue (called stromal tumour-infiltrating lymphocytes, or sTILs), as assessed by a pathologist using a standard scoring method.

Who may not be able to join:

• People who have cancer in both breasts at the same time.
• People who have a history of another cancer that currently requires active treatment, or that carries a significant risk of spreading throughout the body, in the opinion of the treating doctor.
• People where there is a suspicion of, or confirmed evidence of, cancer that has spread to other parts of the body (metastatic disease).
• People whose primary tumour shows signs of growing into the skin or chest wall, or is causing pain that suggests it may be spreading rapidly into nearby muscles or skin, in the opinion of the enrolling doctor.
• People who have previously received certain immunotherapy drugs that work on immune checkpoints or related pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar agents) — though people who received these more than 3 years ago for a different cancer may be considered if the treating doctor determines there is no significant risk of that cancer returning.
• People who have a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have been diagnosed with an immune system deficiency, or who are currently taking high-dose steroid medications (above the equivalent of 10 mg of prednisone daily) or other immune-suppressing treatments within 7 days before the first dose.
• People who have received a live vaccine within 30 days before the first dose (examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and some typhoid and flu vaccines). Additionally, COVID-19 vaccinations should not be scheduled within 72 hours before or after certain dosing days in this trial.
• People who require ongoing treatment with corticosteroids above 10 mg prednisone equivalent per day, or other immune-suppressing medications, within 14 days before starting the study drug (inhaled or topical steroids, and low-dose replacement therapy, may be permitted — confirm with trial site).
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in and follow the requirements of the trial.
• People who are currently pregnant or breastfeeding.
• People who have a history of lung inflammation (pneumonitis, not caused by infection) that required steroid treatment, or who currently have pneumonitis.
• People who have previously received a transplanted organ or tissue from another person.
• People who have an active autoimmune disease that has required treatment with immune-suppressing medications above a low-dose threshold within the past 2 years (note: hormone or enzyme replacement therapies such as thyroid medication or insulin are not counted as immune-suppressing treatment).
• People who have another known cancer (apart from their current breast cancer) that is progressing or has required active treatment within the past 3 years — though people with certain skin cancers or non-invasive cancers that have been successfully treated are not excluded.
• People with any other medical condition, treatment history, or abnormal test result that the treating doctor believes could affect the trial results, interfere with full participation, or would not be in the person's best interest.
• People who have an active infection currently requiring treatment through an IV or injected antibiotic (oral antibiotics for a urinary tract infection, or preventive antiviral medications, may be permitted — confirm with trial site).
• People with a known history of HIV infection.
• People with a known history of active Hepatitis B or currently active Hepatitis C infection (people who have naturally developed immunity to Hepatitis B may still be eligible — confirm with trial site).
• People with any known history of active tuberculosis (TB).

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