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:

• Adults aged 18 or older.
• People who have been diagnosed with breast cancer that has come back or spread to other parts of the body, and whose cancer tests positive for a protein called HER2 (confirmed by laboratory testing of tissue samples).
• People whose cancer has been tested to determine whether it is fuelled by hormones (hormone receptor status is known from recent lab results).
• People who have at least one area of cancer in the body that can be measured using standard imaging methods.
• People who have received no more than one previous treatment for their advanced or metastatic breast cancer (this could include anti-HER2 therapy, chemotherapy, targeted therapy, immunotherapy, or similar).
• People who are generally well enough to carry out light activity and care for themselves daily (a standard medical score of 0 or 1 on a fitness scale used in cancer trials).
• People whose blood, liver, kidney, and heart function results meet the minimum levels required by the trial (confirmed by blood tests, an ECG heart tracing, and a heart ultrasound).
• People who previously took a specific type of targeted drug called a TKI (such as pyrotinib or neratinib) before or after surgery, as long as their cancer did not progress while taking it, and at least 6 months passed between stopping that drug and the cancer returning or spreading.
• People who have recovered from most side effects of any previous cancer treatments before starting this trial, with the exception of hair loss or skin colour changes.
• People who are willing to take part voluntarily, have signed a consent form, and are willing to attend follow-up appointments.

Who may not be able to join:

• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms.
• People with active brain metastases, unless those metastases have no symptoms and have been stable for at least 4 weeks following local treatment.
• People who have difficulty swallowing, a bowel blockage, or any other condition that would affect the ability to take the study drug by mouth and absorb it properly.
• People with large, uncontrolled fluid build-up in body cavities (such as around the lungs or abdomen) that cannot be managed by drainage or other means.
• People who have received radiotherapy, chemotherapy, or targeted therapy within the 4 weeks before joining, or hormone therapy within the 2 weeks before joining — or who are currently taking part in another clinical drug trial. (Bone-strengthening medications such as bisphosphonates are an exception to this rule.)
• People who are pregnant, breastfeeding, have a positive pregnancy test at the start of the trial, or are unwilling to use effective contraception during the study.
• People who have had another active cancer in the past 5 years (certain fully cured skin cancers and cervical pre-cancers may be exempt — confirm with trial site).
• People who have had major surgery or a serious physical injury within 4 weeks before joining the trial, or who are expected to need major surgery during the study.
• People with a known allergy to any ingredient in the study drug.
• People with heart problems, including heart failure, a previous full-thickness heart attack, chest pain requiring medication, significant heart valve disease, or serious abnormal heart rhythms.
• People with active hepatitis B or hepatitis C infections, based on specific blood test results.
• People with uncontrolled high blood pressure (resting readings above 160/100 mmHg).
• People with a confirmed history of serious neurological or psychiatric conditions, including epilepsy or dementia.
• People who, in the treating doctor's judgement, have any other medical condition that could make participation unsafe or interfere with the study.

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