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 are able to read, understand, and sign a consent form agreeing to take part
• People who are over 18 years old at the time of joining the study
• People who are willing to have surgery and are considered medically suitable for it
• People who are generally well enough to carry out normal daily activities with little or no limitation (based on a standard fitness scale called ECOG, scored 0 or 1)
• People whose breast tumor measures more than 1 cm but no larger than 3 cm on ultrasound, with no sign that cancer has spread to the lymph nodes or elsewhere in the body
• People whose breast cancer tests positive for a protein called HER2, as confirmed using standard testing guidelines — both hormone receptor-positive and hormone receptor-negative breast cancers may be included
• People whose heart is pumping at a normal level, confirmed by a heart scan done within 4 weeks before starting the study drug
• People whose blood tests show that their blood counts, liver, and kidneys are working within acceptable levels (confirm with trial site for exact values)
• People who are not able to have children, or who are willing to use effective contraception throughout the study and for at least 12 months after treatment ends — male participants must also agree not to donate sperm, and female participants must agree not to donate eggs, for the same period
• Female participants of childbearing potential who have a negative pregnancy test within 3 days before the first dose of the study drug

Who may not be able to join:

• People who are involved in planning or running this study
• People who have or have had another cancer that could interfere with the safety or results of this trial
• People who have already received any treatment for their current breast cancer diagnosis, including surgery, radiation, chemotherapy, hormone therapy, targeted therapy, or any experimental treatment
• People who have a specific type of irregular heart rhythm on an ECG (a heart tracing measurement called QTc of 470 ms or more)
• People who have an uncontrolled ongoing illness, such as an active infection, active stomach ulcer, uncontrolled bleeding, or a mental health or personal situation that would make it difficult to follow the study requirements
• Female participants who are pregnant, breastfeeding, or of childbearing potential and not using an effective form of contraception
• People who have seizures that are not well controlled
• People who have had major surgery within 4 weeks before joining (placement of a portacath, a type of small device for delivering medication, is allowed)
• People with significant heart problems, including certain irregular heart rhythms, a recent heart attack or unstable chest pain within the past 6 months, any history of heart failure, or high blood pressure that is not controlled despite medication
• People with a currently active Hepatitis B or Hepatitis C infection
• People who are known to be HIV positive
• People who have previously received a high cumulative dose of a specific type of chemotherapy drug called an anthracycline (such as doxorubicin) that exceeds a certain lifetime limit (confirm with trial site for exact threshold)
• People who are currently taking high-dose steroid tablets or other immune-suppressing medications within the 14 days before joining — some low-dose or short-term steroid uses may still be acceptable (confirm with trial site)
• People who have had a serious, life-threatening allergic reaction to a type of medication called a monoclonal antibody or to similar biological medicines
• People who have cancer that has spread to distant parts of the body, including the brain or surrounding tissues
• People with uncontrolled kidney disease, pancreatitis, or serious liver disease that is not stable
• People who have had a symptomatic blood clot in the lungs within the past 28 days
• People who have received a live vaccine within 4 weeks before joining the study — non-live COVID-19 vaccines may be permitted before or during the study, provided there is at least a 48-hour gap between the vaccine and the study drug

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