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 not yet received any treatment for their breast cancer and who are willing to take part and provide written consent
• People whose breast cancer has been confirmed by tissue testing as hormone receptor-positive (HR+) and HER2-negative
• People whose cancer meets at least one of the following: the tumor is larger than 2 cm, cancer has spread to the lymph nodes under the arm, or the person wishes to have breast-conserving surgery but the size of the tumor compared to the breast makes this difficult
• People aged 18 or older who are generally well enough to carry out daily activities without significant limitation (confirm with trial site for exact fitness level required)
• People whose blood test results meet required levels for white blood cells, infection-fighting cells (neutrophils), platelets, and haemoglobin, as assessed by the trial site
• People whose liver function blood test results are within acceptable ranges, as assessed by the trial site
• People whose kidney function is within acceptable levels, as assessed by the trial site
• People whose blood clotting test results are within acceptable ranges, as assessed by the trial site

Who may not be able to join:

• People who have received chemotherapy, targeted therapy, or radiotherapy in the 12 months before starting the trial, or who have had an organ or bone marrow transplant
• People who have had a heart attack or uncontrolled heart rhythm problems in the 6 months before starting the trial, including certain abnormal heart rhythm readings on an ECG (confirm with trial site)
• People with moderate to severe heart failure, a weakened pumping function of the heart, or high blood pressure that is not well controlled
• People with active HIV, tuberculosis, a lung condition called interstitial lung disease, serious breathing problems, or immune system conditions requiring ongoing treatment to suppress the immune system
• People who have received a live vaccine within 28 days before starting the trial (note: certain inactivated flu vaccines may be permitted — confirm with trial site)
• People who are taking high-dose steroid tablets or immune-suppressing medications within 14 days before starting the trial, unless the use is short-term, low-dose, applied to the skin, or for replacing hormones the body cannot produce (confirm with trial site)
• People with an active infection requiring treatment, or hepatitis B or C with detectable levels of virus in the blood
• People who have previously been treated with certain immunotherapy drugs (immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies)
• People who are currently taking part in another clinical trial, or have done so within the 14 days before starting
• People who have had major surgery within 4 weeks before starting the trial (minor procedures such as biopsies are generally excluded from this rule — confirm with trial site)
• People with a history of severe allergic reactions to monoclonal antibody treatments or to the ingredients in the study drugs
• People who are pregnant or breastfeeding
• People with active psychiatric conditions or a history of substance abuse (note: people who have previously consumed alcohol but have stopped may still be considered — confirm with trial site)
• People whom the trial investigators consider unsuitable for participation for any other medical reason

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