In breve
Clinical trials are investigating "(R)-N-(4-([1,2,4]-TRIAZOLO[1,5-C]-PYRIMIDIN-7-YLOXY)-3-METHYLPHENYL)-5-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-6-METHOXYQUINAZOLIN-4-AMINE" in people with pretreated, unresectable, locally advanced or metastatic HER2-positive breast cancer, with or without CNS metastases. The main goal is to compare effectiveness and safety against an active treatment option and to measure progression-free survival.
Punti chiave
- Clinical trials are studying "(R)-N-(4-([1,2,4]-TRIAZOLO[1,5-C]-PYRIMIDIN-7-YLOXY)-3-METHYLPHENYL)-5-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-6-METHOXYQUINAZOLIN-4-AMINE" in people with pretreated, unresectable locally advanced or metastatic HER2-positive breast cancer. The trial includes patients with or without CNS metastases. It is a Phase 4 interventional study with 650 participants. The main goal is to compare effectiveness and safety against tucatinib-based treatment. The main endpoint is progression-free survival in the full analysis set.
Trial overview
This clinical trial is studying (R)-N-(4-([1,2,4]-TRIAZOLO[1,5-C]-PYRIMIDIN-7-YLOXY)-3-METHYLPHENYL)-5-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-6-METHOXYQUINAZOLIN-4-AMINE in people with HER2-positive breast cancer that is locally advanced or metastatic and has already been treated before.1 The study is authorised and includes patients with or without CNS metastases, meaning spread to the brain or spinal cord area.1
Who can participate
The trial is for people with pretreated unresectable locally advanced or metastatic HER2-positive breast cancer.1 “Pretreated” means the person has already received cancer treatment, and “unresectable” means surgery cannot remove the cancer completely.1 The trial also allows people with or without CNS metastases.1
Treatments being compared
This is a comparison trial.1 One group receives (R)-N-(4-([1,2,4]-TRIAZOLO[1,5-C]-PYRIMIDIN-7-YLOXY)-3-METHYLPHENYL)-5-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-6-METHOXYQUINAZOLIN-4-AMINE with trastuzumab and capecitabine, while the other group receives tucatinib with trastuzumab and capecitabine.1 The trial is designed to see which combination gives better results and how safe it is.1
Study phase and design
This is a Phase 4 interventional study.1 Phase 4 means the treatment is being studied in a later stage, often to learn more about how it performs in a larger group of patients.1 The planned enrollment is 650 participants.1
What the trial measures
The main endpoint is progression-free survival in the full analysis set.1 Progression-free survival means the length of time during which the cancer does not get worse.1 The full analysis set is the main group of participants used to analyze the results.1
What this means for patients
For patients, this trial is mainly about finding out whether the study treatment combination works better than the comparison treatment in a difficult-to-treat form of breast cancer.1 The focus is not only on cancer control but also on safety in the studied patient group.1 Because the trial includes people with advanced disease and possible CNS metastases, it is aimed at patients with more complex cancer situations.1