Phase 3 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 who are willing to take part and sign a consent form agreeing to participate
• People aged 18 or older
• People who are generally well enough to carry out daily activities with little or no limitation (assessed using a standard medical scale called ECOG, with a score of 0 or 1)
• People whose breast cancer has been confirmed as invasive by a tissue or cell sample test
• People who have already had surgery to remove breast cancer, either full breast removal or breast-conserving surgery
• People whose cancer has been confirmed to have spread to nearby lymph nodes
• People whose tumor has been tested and confirmed as HER2-positive by a local laboratory
• People whose blood tests show that their bone marrow, liver, kidneys, and heart are functioning well enough to meet specific levels set by the trial
• People of childbearing potential who have a negative pregnancy blood test within 7 days before joining the trial, and who agree to use reliable contraception during treatment and for 7 months after the last dose — this applies to both female participants and male participants whose partners could become pregnant

Who may not be able to join:

• People who have had a previous invasive breast cancer in either breast
• People who have had another type of cancer in the past 5 years, unless it was an easily treatable localised cancer treated with the aim of cure
• People who have previously received chemotherapy, hormone therapy, anti-HER2 targeted therapy, or radiotherapy for breast cancer
• People who have used certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors) within the 14 days before joining, or who plan to use them during the chemotherapy part of the trial (confirm with trial site)
• People who are known to have an allergy or sensitivity to any of the study drugs or their ingredients
• People with a significant heart or blood vessel condition, including prior heart bypass surgery or stenting, a heart attack or stroke within the past 6 months, a history of heart failure or weak heart pumping, unstable chest pain, certain abnormal heart rhythms, a specific abnormality on a heart trace (QTcF greater than 450 ms), or severely uncontrolled high blood pressure
• People who have had a serious infection requiring intravenous antibiotics or antiviral treatment within the 14 days before joining
• People who have taken part in another interventional clinical trial within the past 4 weeks
• People who are pregnant or breastfeeding
• People with any other condition that may affect their ability to follow the trial procedures or that may not make participation in their best interest, such as a history of neurological or psychiatric conditions, alcohol or drug misuse, or another significant illness (confirm with trial site)

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