In short
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, with or without CNS metastases. The main goal is to compare effectiveness and safety against an active treatment and measure progression-free survival.
Key points
- 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 study includes patients with or without CNS metastases. It is a Phase 4 interventional trial with 650 planned participants. The main goal is to compare this treatment combination with tucatinib-based therapy. The key endpoint is progression-free survival in the full analysis set.
Trial overview
This clinical trial is testing "(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.1 The study also includes people with or without central nervous system (CNS) metastases, which means cancer spread to the brain or spinal cord area.1
Who is being studied
The target population is people who have already received treatment before and still have breast cancer that cannot be removed by surgery.1 The trial includes both locally advanced disease and metastatic disease, so it is focused on more advanced cancer stages.1
People may be included whether or not they have CNS metastases.1 This makes the study relevant for patients whose cancer has spread beyond the breast, including the brain or spinal cord area.1
Treatments being compared
The study compares two treatment combinations: "(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, versus tucatinib with trastuzumab and capecitabine.1
The brief summary says the main aim is to compare the effectiveness of the two combinations, so the trial is not only looking at one treatment by itself.1 It is comparing one study combination against another active treatment combination already used in the trial.1
Trial phase and design
This is a Phase 4 trial, which means it is a later-stage study done in a larger group of people.1 The study type is interventional, meaning researchers assign treatments and then measure outcomes.1
The planned enrollment is 650 participants.1 The trial status is authorised.1
Endpoints being measured
The main endpoint is progression-free survival in the full analysis set (PFS-FAS).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 for analysis.1 This endpoint helps show whether one treatment combination keeps the cancer under control longer than the other.1
What the results will help answer
The trial is designed to help answer whether the study combination with "(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" is more effective than the tucatinib-based combination in this patient group.1 It also helps researchers compare the safety and overall performance of the two treatment strategies in advanced HER2-positive breast cancer.1