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 given their voluntary written agreement to take part in the trial
• People aged 18 years or older
• People who have been diagnosed with invasive breast cancer (confirmed by tissue biopsy), with a tumour larger than 2 cm, and where the cancer has not spread to distant parts of the body
• People whose breast cancer tumour has been confirmed as HER2-positive by a central laboratory test, and who are able to provide tumour tissue samples for HER2 testing
• People who are able to tolerate and are planned to have surgery to remove the breast cancer, and who have not yet received any treatment for their breast cancer
• People who have at least one tumour that can be measured on scans, according to standard criteria
• People whose heart is functioning well enough — specifically, heart function rated below class 3 on a standard scale, and the heart's pumping strength (left ventricular ejection fraction) is at least 55%
• People whose blood counts, liver function, kidney function, and blood clotting levels all meet the required levels within 7 days before starting the study treatment (without having received blood transfusions or certain boosting medications in the 14 days before those tests)
• People who could become pregnant, who agree to have a negative pregnancy test within 72 hours before the first dose, use at least two forms of contraception (including one highly effective method) throughout the study and for at least 6–7 months after the last dose, not breastfeed or donate eggs during this period
• People who could father a child, who agree not to donate sperm and to use at least two forms of contraception (including one highly effective method) throughout the study and for at least 4–7 months after the last dose, and to use a condom if their partner is pregnant or breastfeeding
• People who are able to understand what the trial involves and are willing and able to follow all trial procedures and follow-up visits

Who may not be able to join:

• People who have invasive breast cancer in both breasts
• People who have a previous history of invasive breast cancer
• People who previously had non-invasive breast cancer (carcinoma in situ) and received hormone therapy within 5 years of that surgery
• People who have previously received certain types of immunotherapy drugs (such as PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors) or antibody-drug combinations
• People who have previously received any anti-HER2 treatment
• People who have taken an experimental drug or had major surgery within 4 weeks before starting the study treatment
• People who have received a live vaccine within 4 weeks before starting the study treatment, or who plan to receive one during the study
• People who have previously had a bone marrow transplant or an organ transplant
• People with serious or uncontrolled heart conditions, including severe heart failure, a heart attack or stroke in the past 6 months, pulmonary embolism, unstable chest pain, abnormal heart rhythms requiring treatment, certain heart muscle diseases, significant abnormalities in heart electrical activity, atrial fibrillation of a certain severity, or uncontrolled high blood pressure judged by the doctor to be unsuitable for participation
• People with a history of interstitial lung disease (scarring or inflammation of the lungs) that required treatment, or who currently have severe lung conditions including active tuberculosis
• People with a clear past or current history of a neurological or psychiatric disorder, including epilepsy or dementia
• People with ongoing nerve damage (sensory or movement problems) rated as moderate or severe (grade 2 or higher)
• People with an active infection that requires systemic (whole-body) treatment, or who had such an infection within 7 days before starting treatment; people who test positive for HIV; people with active hepatitis B or C; or people with an ongoing COVID-19 infection
• People who have an active autoimmune disease that has required systemic treatment (such as steroids or immune-suppressing medicines) within the past 2 years (some hormone replacement therapies may be permitted — confirm with trial site)
• People who have had another cancer within the past 5 years, with some exceptions such as certain early-stage or non-spreading skin cancers, cervical carcinoma in situ, or other cancers considered fully cured (confirm with trial site)
• People who are known to have had a serious allergic reaction to any of the study drugs or similar medicines
• People who have another medical condition that the doctor considers to be a serious risk to their safety or that would prevent them from completing the trial

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