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(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

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.

Table of contents

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]

Trial IDPhaseCondition studiedStatusEnrollmentMain endpoint
2025-524498-17-00Phase 4Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without CNS metastasesAuthorised650Progression-Free Survival in Full Analysis Set (PFS-FAS)

Ongoing Clinical Trials on (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

  • Comparing RO7771950 with a drug combination of tucatinib, trastuzumab, and capecitabine in patients with HER2-positive metastatic or locally advanced breast cancer

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +5

Glossary

  • HER2-positive breast cancer: A type of breast cancer that has too much of a protein called HER2. This can affect how the cancer grows and which treatments are studied.
  • Locally advanced: Cancer that has grown outside the original area but has not clearly spread to distant parts of the body.
  • Metastatic: Cancer that has spread to other parts of the body.
  • Unresectable: Not able to be removed with surgery.
  • Pretreated: The cancer has already been treated before this study.
  • Central nervous system (CNS) metastases: Cancer that has spread to the brain or spinal cord area.
  • Interventional study: A study where researchers give one or more treatments and compare outcomes.
  • Phase 4: A later-stage trial that looks at how a treatment performs in a larger group after it is already being used.
  • Progression-free survival: The length of time during which a person lives without the cancer getting worse.
  • Full analysis set (FAS): The main group of study participants used for the final analysis.
  • Trastuzumab: A treatment used in the study combination. The trial compares two treatment groups that include this medicine.
  • Capecitabine: A treatment used in the study combination. It is given together with the other trial treatments.