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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 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.

Table of contents

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]

Trial ID Phase Condition studied Status Enrollment Main endpoint
2025-524498-17-00 Phase 4 Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without CNS metastases Authorised 650 Progression-free survival in full analysis set (PFS-FAS)

Sperimentazioni cliniche in corso su (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

  • Studio comparativo tra RO7771950, trastuzumab e capecitabina rispetto a tucatinib, trastuzumab e capecitabina in pazienti con tumore al seno HER2-positivo metastatico o avanzato

    In arruolamento

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    Malattie in studio:
    Farmaci in studio:
    Austria Belgio Cechia Francia Germania Ungheria +5

Glossario

  • HER2-positive: A type of breast cancer that has too much of a protein called HER2 on the cancer cells. This can affect how the cancer grows and which treatments may help.
  • Locally advanced: Cancer that has grown beyond its original place 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 fully with surgery.
  • Pretreated: The patient has already received one or more cancer treatments before joining the study.
  • CNS metastases: Cancer that has spread to the central nervous system, which includes the brain and spinal cord.
  • Phase 4: A later stage of clinical research that studies a treatment in real-world or broader use after earlier testing.
  • Interventional study: A study where researchers give specific treatments and compare the results.
  • Progression-free survival: The length of time during and after treatment when the cancer does not get worse.
  • Full analysis set: A group of study participants included in the main analysis of trial results.
  • Trastuzumab: A treatment used in the trial combination being studied.
  • Capecitabine: A treatment used in the trial combination being studied.