Phase 3 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:

• Women between 18 and 75 years old who have been diagnosed with breast cancer that has spread to other parts of the body, confirmed by a pathology report or scan.
• People whose breast cancer has been tested and confirmed as HER2-positive through specific laboratory tests (IHC 3+, or IHC 2+ with a positive FISH test).
• People who have not yet received any chemotherapy for their metastatic (spread) breast cancer.
• People who have at least one tumour that can be measured on a scan, according to standard criteria used in cancer trials.
• People whose general health and ability to carry out daily activities meets a certain level (ECOG score of 2 or below), and who are expected to live for at least 3 months.
• People whose side effects from any previous cancer treatment have largely resolved before joining the trial (except for hair loss or other effects the doctor considers low risk).
• People whose blood cell counts meet minimum levels — including white blood cells, neutrophils (infection-fighting cells), and platelets — as confirmed by blood tests.
• People whose liver, kidney, and heart function fall within acceptable ranges as shown by blood and heart tests.
• People whose heart pumping function (LVEF) is at least 55%, and whose heart rhythm measurement (QTcF) is within an acceptable range.
• People whose hormone receptor status (whether the cancer responds to hormones) has been clearly determined.
• Women who could become pregnant must have a negative pregnancy test before joining, and must agree to use an effective non-hormonal method of contraception during the trial and for at least 6 months after the last dose of the study drug.
• People who understand what the study involves, are willing to take part voluntarily, and have signed a consent form.

Who may not be able to join:

• People whose cancer has been tested and found to be HER2-negative (IHC 2+ with a negative FISH test, or IHC 1+).
• People who are known to have had an allergic reaction to the study drug or any of its ingredients.
• People who are pregnant or breastfeeding, those who test positive on a pregnancy test at the start of the trial, or those who are unwilling to use effective contraception throughout the trial.
• People who have a pre-existing health condition that could interfere with taking part in the study or could affect their safety — for example, uncontrolled heart disease, high blood pressure, an active or uncontrolled infection, or active hepatitis B — as determined by the trial doctor.

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