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:

• People aged 18 or older.
• People who are willing to give written consent to take part in the study.
• People who have been diagnosed with breast cancer confirmed by a tissue or cell sample test.
• People whose breast cancer tests positive for oestrogen receptors (ER+) and shows high levels of the HER2 protein (HER2-positive), based on standard lab tests. Previous test results may be accepted.
• People with advanced or metastatic breast cancer who have already received treatment with trastuzumab (or a similar version of it) that has stopped working, or whose cancer came back during or within 12 months of finishing trastuzumab treatment, or who have had one line of treatment for relapsed disease, or who are not suitable for trastuzumab treatment. People whose cancer has stopped responding to a previous HER2-targeted antibody-drug treatment may also be considered.
• People who have at least one area of cancer that can be measured or assessed using CT or MRI scans, following specific measurement guidelines (RECIST v1.1).
• People who are able to carry out basic daily activities with little or no limitation, based on a standard activity scale (ECOG score of 0 or 1).
• People whose estimated life expectancy is more than 3 months.
• Women who are post-menopausal, which may be defined by having had both ovaries removed, being aged 60 or older, being under 60 with no natural period for 12 or more months and hormone levels in the post-menopausal range, or being under 60 and taking certain hormone-blocking medicines with hormone levels in the post-menopausal range. Women who have not yet reached menopause may also be considered, but only if they are receiving an approved treatment to suppress ovarian function, which must have been started at least 21 days before joining the study and continued throughout.
• People with adequate bone marrow, liver, kidney, and blood clotting function, based on specific blood test results measured before joining the study.
• People whose side effects from any previous treatments have mostly resolved (to a mild level or below), except for hair loss, skin pigmentation changes, or certain lasting effects from radiotherapy.
• Women of childbearing age (and their partners) who have no plans to become pregnant and are willing to use effective contraception from the time of signing consent until 3 months after the last dose of study medication.

Who may not be able to join:

• People experiencing a serious internal organ crisis, where one or more vital organs are failing rapidly and require urgent treatment.
• People who have cancer that has spread to the spinal cord, brain, or the lining around the brain.
• People who have previously been treated with a small-molecule HER2 targeted tablet medicine (called a HER2 tyrosine kinase inhibitor), unless the course of treatment lasted 2 weeks or less.
• People who have received radiotherapy within the 4 weeks before joining the study.
• People who have received more than one course of chemotherapy for advanced breast cancer, or who have not stopped chemotherapy at least 4 weeks before joining.
• People who require feeding directly into a vein, have a condition affecting how the body absorbs food or medicines, or are unable to swallow tablets.
• People who have taken medicines that strongly affect how the liver breaks down the study drug (Hemay022) within the 2 weeks before the study, or who would need to take such medicines during the study (confirm with trial site for specific medicines).
• People with a known allergy to the study drug (Hemay022), lapatinib, certain hormone-blocking medicines (letrozole or exemestane), capecitabine, or similar medicines.
• People whose heart pumping function (left ventricular ejection fraction) is below 50%, as measured by a heart scan.
• People who test positive for HIV, have active hepatitis B with detectable virus in the blood, or have active hepatitis C infection.
• People who have an active infection currently requiring antibiotics or antiviral treatment given through a drip.
• People with certain heart rhythm problems requiring treatment, including atrial fibrillation, certain rapid heartbeat conditions, or ventricular fibrillation; people with coronary heart disease needing ongoing medication; people who have had a heart attack in the past year; or people with heart failure.
• People whose heart's electrical activity shows a specific abnormality (QTc interval of 500ms or more) on an ECG.
• People who have a history of a lung condition called interstitial lung disease that has required treatment, a history of radiation-related lung inflammation, or currently active interstitial lung disease.
• People who have taken part in another clinical trial and received a study drug within the 4 weeks before joining.
• People who have had major surgery or a significant injury within the 4 weeks before joining.
• People who would need to continue other cancer treatments (such as chemotherapy, targeted therapy, hormone therapy, immunotherapy, or radiotherapy) during the study, except for certain localised radiotherapy for symptom relief.
• People who have had another cancer in the past 5 years, except for certain early-stage skin cancers or cervical cancer confined to the surface that have been fully treated.
• People whom the trial doctor considers unsuitable for the study for any other reason.

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